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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01878617
Registration number
NCT01878617
Ethics application status
Date submitted
10/06/2013
Date registered
17/06/2013
Date last updated
18/01/2024
Titles & IDs
Public title
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
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Scientific title
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
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Secondary ID [1]
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NCI-2013-01125
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Secondary ID [2]
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SJMB12
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medulloblastoma
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Condition category
Condition code
Cancer
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Children's - Brain
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Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Craniospinal Irradiation with boost to the primary tumor site
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cisplatin
Treatment: Drugs - Vincristine
Treatment: Drugs - Vismodegib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Gemcitabine
Other interventions - Aerobic Training
Other interventions - Neurocognitive Remediation
Experimental: Stratum W1: Low Risk - Participants in stratum W1 will undergo reduced dose Craniospinal Irradiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum W2: Atypical - Participants in stratum W2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum W3: High Risk - Participants in stratum W3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum S1: Standard Risk - Participants in stratum S1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum S2: High Risk - Participants in stratum S2 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum N1: Standard Risk - Participants in stratum N1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum N2: Intermediate Risk - Participants in stratum N2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Experimental: Stratum N3: High Risk - Participants in stratum N3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.
Treatment: Other: Craniospinal Irradiation with boost to the primary tumor site
All participants will undergo craniospinal irradiation (CSI) with boost to the primary tumor site. The dose given is based on the molecular and risk group as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.
Treatment: Drugs: Cyclophosphamide
Route of Administration (ROA): Intravenously (IV)
Treatment: Drugs: Cisplatin
ROA: IV
Treatment: Drugs: Vincristine
ROA: IV
Treatment: Drugs: Vismodegib
ROA: Orally (PO)
Treatment: Drugs: Pemetrexed
ROA: IV
Treatment: Drugs: Gemcitabine
ROA: IV
Other interventions: Aerobic Training
Other interventions: Neurocognitive Remediation
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival in Stratum W1
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Assessment method [1]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact.
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Timepoint [1]
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2 years after diagnosis
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Primary outcome [2]
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Progression-free Survival in Stratum N1
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Assessment method [2]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact.
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Timepoint [2]
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2 years after diagnosis
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Primary outcome [3]
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Progression-free Survival in Stratum S1 Skeletally Mature Cohort
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Assessment method [3]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum S1 skeletally mature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [3]
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2 years after diagnosis
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Primary outcome [4]
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Change in VO2 Peak Value
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Assessment method [4]
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To evaluate the effect of an aerobic training intervention on cardiopulmonary fitness.
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Timepoint [4]
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baseline and 12 weeks post-randomization
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Primary outcome [5]
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Change in Spatial Span Backward Standard Score
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Assessment method [5]
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To assess the impact of a computer-based working memory intervention, relative to standard of care, on a performance-based measure of working memory.
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Timepoint [5]
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baseline and 10-12 weeks post baseline
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Secondary outcome [1]
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Progression-free Survival in Stratum W1 Compared to Historical Controls
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Assessment method [1]
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Progression-free survival (PFS) in stratum W1 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [1]
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2 years after diagnosis
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Secondary outcome [2]
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Overall Survival in Stratum W1
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Assessment method [2]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum W1 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [2]
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2 years after diagnosis
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Secondary outcome [3]
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Progression-free Survival in Stratum S1 Skeletally Immature Cohort
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Assessment method [3]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum S1 skeletally immature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [3]
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2 years after diagnosis
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Secondary outcome [4]
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Progression-free Survival in Stratum S2 Skeletally Mature Cohort
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Assessment method [4]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum S2 skeletally mature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [4]
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2 years after diagnosis
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Secondary outcome [5]
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Progression-free Survival in Stratum S2 Skeletally Immature Cohort
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Assessment method [5]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum S2 skeletally immature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [5]
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2 years after diagnosis
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Secondary outcome [6]
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Overall Survival in Stratum S1 Skeletally Mature Cohort
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Assessment method [6]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum S1 skeletally mature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [6]
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2 years after diagnosis
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Secondary outcome [7]
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0
Overall Survival in Stratum S1 Skeletally Immature Cohort
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Assessment method [7]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum S1 skeletally immature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [7]
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2 years after diagnosis
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Secondary outcome [8]
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Overall Survival in Stratum S2 Skeletally Mature Cohort
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Assessment method [8]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum S2 skeletally mature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [8]
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2 years after diagnosis
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Secondary outcome [9]
0
0
Overall Survival in Stratum S2 Skeletally Immature Cohort
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Assessment method [9]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum S2 skeletally immature cohort will be compared to historical controls from SJMB03 as well as from another published cohort (Thompson et al., 2016) using log-rank test.
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Timepoint [9]
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2 years after diagnosis
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Secondary outcome [10]
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0
Progression-free Survival in Stratum N2
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Assessment method [10]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum N2 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [10]
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2 years after diagnosis
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Secondary outcome [11]
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Overall Survival in Stratum N2
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Assessment method [11]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum N2 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [11]
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2 years after diagnosis
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Secondary outcome [12]
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0
Progression-free Survival in Stratum N3
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Assessment method [12]
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Progression-free survival (PFS) will be measured from diagnosis to the earliest of disease progression or death from any cause. Patients who have not experienced one of these events will be censored at their last date of contact. PFS in SJMB12 stratum N3 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [12]
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2 years after diagnosis
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Secondary outcome [13]
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0
Overall Survival in Stratum N3
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Assessment method [13]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum N3 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [13]
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2 years after diagnosis
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Secondary outcome [14]
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Progression-free Survival in Stratum N1 Compared to Historical Controls
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Assessment method [14]
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Progression-free survival (PFS) in stratum N1 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [14]
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2 years after diagnosis
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Secondary outcome [15]
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0
Overall Survival in Stratum N1
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Assessment method [15]
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Overall survival (OS) will be measured from diagnosis to death from any cause. Patients who survive will be censored at their last date of contact. OS in SJMB12 stratum N1 will be compared to historical controls from SJMB03 using log-rank test.
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Timepoint [15]
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2 years after diagnosis
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Secondary outcome [16]
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Percentage of Participants Who Complete Pemetrexed and Gemcitabine Therapy
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Assessment method [16]
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Intermediate and high risk Non-WNT Non-SHH medulloblastoma patients treated on strata N2 and N3 will receive pemetrexed and gemcitabine during adjuvant chemotherapy. Percentage of participants who complete treatment will be estimated and reported with an exact 2-sided 95% confidence interval.
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Timepoint [16]
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10 months after on treatment
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Secondary outcome [17]
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Percentage of Participants Who Complete Vismodegib Therapy
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Assessment method [17]
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Patients with SHH tumor treated on strata S1 and S2 will receive 12 courses of vismodegib during maintenance therapy. For each risk-based stratum separately, percentage of participants who complete treatment will be estimated and reported with an exact 2-sided 95% confidence interval.
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Timepoint [17]
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20 months after on treatment
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Secondary outcome [18]
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Number of Local Failures
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Assessment method [18]
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To estimate stratum specific cumulative incidence of local disease failure at 2 and 5 years.
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Timepoint [18]
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2 and 5 years after on treatment
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Secondary outcome [19]
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Change in hand grip strength
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Assessment method [19]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on hand grip strength as measured using a hand-held dynamometer among children treated for medulloblastoma. Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, the average used for analysis.
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Timepoint [19]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [20]
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Change in range of motion
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Assessment method [20]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on range of motion as measured with a goniometer among children treated for medulloblastoma. The goniometer is a reliable and valid measure of active and passive range of motion with standard procedures.
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Timepoint [20]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [21]
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Change in overall flexibility
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Assessment method [21]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on overall flexibility among children treated for medulloblastoma. Flexibility will be measured by having participants perform a "sit and reach test." A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs, with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, and the best value for three trials, in centimeters, at the fingertips is recorded.
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Timepoint [21]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [22]
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Change in motor proficiency
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Assessment method [22]
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Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Version 2 (BOT-2). To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on motor proficiency among children treated for medulloblastoma.
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Timepoint [22]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [23]
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Change in quality of life (QOL) score
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Assessment method [23]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy on health related quality of life (QoL) among children treated for medulloblastoma. QoL will be assessed using the 23-item PedsQL(TM) 4.0 Generic Core Scales which encompasses four subscales (1) physical functioning (eight items), (2) emotional functioning (five items), (3) social functioning (five items), and (4) school functioning (five items) and the 24-item PedsQL(TM) Brain Tumor Module which encompasses six scales: (1) cognitive problems (seven items), (2) pain and hurt (three items), (3) movement and balance (three items), (4) procedural anxiety (three items), (5) nausea (five items), and (6) worry (three items).
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Timepoint [23]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [24]
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Change in fatigue score
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Assessment method [24]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on fatigue among children treated for medulloblastoma. Fatigue will be assessed using the 18-item PedsQL(TM) Multidimensional Fatigue Scale which encompasses three subscales: (1) general fatigue (six items), (2) sleep/rest fatigue (six items), and (3) cognitive fatigue (six items).
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Timepoint [24]
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Baseline (at enrollment), 12 weeks, at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3), and 1, 2, and 5 years after the last patient enrollment
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Secondary outcome [25]
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Change in measure of memory function
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Assessment method [25]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on memory function at the end of the intervention and at the end of adjuvant chemotherapy, among children treated for medulloblastoma. Memory will be measured using different instruments as age appropriate: CogStage for age 5 and older (Continuous Paired Associate Learning task), California Verbal Learning Test, Children's Version (CVLT-C) for age 6 to < 17 years or California Verbal Learning Test, Second Edition (CVLT-II) for age =17 years.
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Timepoint [25]
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Baseline (at enrollment), 12 weeks, and at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3).
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Secondary outcome [26]
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Change in measure of attention
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Assessment method [26]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on attention at the end of the intervention and at the end of adjuvant chemotherapy, among children treated for medulloblastoma. Attention will be measured using different instruments as age appropriate: Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for ages 3 to < 6 years (Digit Span Forward subtest), Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for ages 6 to < 17 years (Digit Span Forward subtest) or Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for ages =17 years (Digit Span Forward subtest). We will also use Conners' Continuous Performance Test, Kiddie Version V.5 for ages 4 to < 6 years and Conner's Continuous Performance Test, Second Edition (CPT-II) for ages =6 years, in addition to Cog Stage for children =5 years (Detection and Identification tasks).
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Timepoint [26]
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Baseline (at enrollment), 12 weeks, and at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3).
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Secondary outcome [27]
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Change in executive function score
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Assessment method [27]
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To evaluate the effects of an aerobic training intervention, delivered during the radiation therapy period and at home, prior to the start of chemotherapy, on executive function at the end of the intervention and at the end of adjuvant chemotherapy, among children treated for medulloblastoma. Executive function is measured as age-appropriate by the following: BRIEF-P (age 3 to <6 years), BRIEF (age 6 to <19 years) and BREIF-A (age =19 years). Connor's Parent Rating Scale, Third Edition (CPRS-III) will also be used for age 6 to <19 years, as well as CogState One-Back and Groton Maze tasks for age =5 years.
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Timepoint [27]
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Baseline (at enrollment), 12 weeks, and at end of adjuvant chemotherapy (28 weeks for strata W1/W2/W3/N1/S1/S2 and 40 weeks for strata N2/N3).
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Secondary outcome [28]
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Change in sleep
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Assessment method [28]
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To evaluate the impact of an aerobic training intervention on sleep quality and quantity in children with medulloblastoma. Sleep quality and quantity will be measured by Actigraph accelerometer as well as a sleep diary.
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Timepoint [28]
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Baseline and 10-12 weeks post randomization
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Secondary outcome [29]
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Association between baseline cognitive performance and sleep quality
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Assessment method [29]
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To evaluate the relation between baseline cognitive performance and sleep quality in children with medulloblastoma. Multivariable general linear mixed models will be used to look for associations between sleep quality as measured by Actigraph accelerometer and a sleep diary with measures of cognitive performance (memory, attention and executive function (detailed above) and internalizing and externalizing behavior. Internalizing and externalizing behaviors will be measured using the Behavior Assessment System for Children, 2nd Edition (BASC-2). There are Preschool, Child and Adolescent versions.
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Timepoint [29]
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Baseline and approximately 7-10 months after treatment
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Secondary outcome [30]
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Association between baseline cognitive performance and sleep quantity
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Assessment method [30]
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To evaluate the relation between baseline cognitive performance and sleep quantity in children with medulloblastoma. Multivariable general linear mixed models will be used to look for associations between sleep quantity as measured by a sleep diary with measures of cognitive performance (memory, attention and executive function and internalizing and externalizing behavior (detailed above).
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Timepoint [30]
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Baseline and approximately 7-10 months after treatment
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Secondary outcome [31]
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Association between baseline cognitive performance and fatigue
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Assessment method [31]
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To evaluate the relation between baseline cognitive performance and fatigue in children with medulloblastoma. Multivariable general linear mixed models will be used to look for associations between fatigue score as measured by the Multidimensional Fatigue Scale with measures of cognitive performance (memory, attention and executive function and internalizing and externalizing behavior (detailed above).
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Timepoint [31]
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Baseline and approximately 7-10 months after treatment
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Secondary outcome [32]
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Longitudinal change in measure of intellectual function
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Assessment method [32]
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Intellectual function will be measured as age-appropriate using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for age 3 to < 6 years, Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for age 6 to < 17 years, and Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for age =17 years. Linear mixed-effects models will be used to model change in intellectual function over time.
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Timepoint [32]
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Baseline through 5 years after enrollment
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Secondary outcome [33]
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Association of demographic and clinical factors with change in intellectual function
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Assessment method [33]
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Intellectual function will be measured as age-appropriate using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for age 3 to < 6 years, Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for age 6 to < 17 years, and Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for age =17 years. Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in intellectual function with demographic and clinical factors.
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Timepoint [33]
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Baseline through 5 years after enrollment
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Secondary outcome [34]
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Longitudinal change in measure of academic ability
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Assessment method [34]
0
0
Academic ability will be measured using the Woodcock Johnson Tests of Academic Achievement-Third Edition (WJ-III-ACH) which has six subsets: Letter-Word Identification, Passage Comprehension, Reading Fluency, Calculation, Applied Problems, and Math Fluency. Academic ability will also be measured using the Comprehensive Test of Phonological Processing (CTOPP) which has three subsets: Elision, Blending Words, and Rapid Naming. Linear mixed-effects models will be used to model change in academic ability over time.
Query!
Timepoint [34]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [35]
0
0
Association of demographic and clinical factors with change in academic ability
Query!
Assessment method [35]
0
0
Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in academic ability (measured as described above) with demographic and clinical factors.
Query!
Timepoint [35]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [36]
0
0
Longitudinal change in measure of attention
Query!
Assessment method [36]
0
0
Attention will be measured using different instruments as age appropriate: Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for ages 3 to < 6 years old (Digit Span Forward subtest), Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for ages 6 to < 17 years (Digit Span Forward subtest) or Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for ages =17 years (Digit Span Forward subtest). We will also use Conners' Continuous Performance Test, Kiddie Version V.5 for ages 4 to < 6 years and Conner's Continuous Performance Test, Second Edition (CPT-II) for ages =6 years, in addition to Cog Stage for children =5 years (Detection and Identification tasks). Linear mixed-effects models will be used to model change in the measure of attention over time.
Query!
Timepoint [36]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [37]
0
0
Association of demographic and clinical factors with change in attention
Query!
Assessment method [37]
0
0
Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in attention (measured as described above) with demographic and clinical factors.
Query!
Timepoint [37]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [38]
0
0
Longitudinal change in measure of memory
Query!
Assessment method [38]
0
0
Memory will be measured using different instruments as age appropriate: CogStage for age 5 and older (Continuous Paired Associate Learning task), California Verbal Learning Test, Children's Version (CVLT-C) for age 6 to < 17 years or California Verbal Learning Test, Second Edition (CVLT-II) for age =17 years. Linear mixed-effects models will be used to model change in memory over time.
Query!
Timepoint [38]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [39]
0
0
Association of demographic and clinical factors with change in memory
Query!
Assessment method [39]
0
0
Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in memory (measured as described above) with demographic and clinical factors.
Query!
Timepoint [39]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [40]
0
0
Longitudinal change in measure of cognitive processing speed function
Query!
Assessment method [40]
0
0
Cognitive processing speed function will be measured using the age-appropriate processing speed indices: WPPSI-IV which has two subsets: Bug Search and Cancellation, for age 3 to < 6 years old; WISC-IV which has two subsets: Coding and Symbol Search subtests, for 6 to < 17 years, and WAIS-IV which has two subsets: Coding and Symbol Search subtests, for age =17 years. Linear mixed-effects models will be used to model change in cognitive processing speed over time.
Query!
Timepoint [40]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [41]
0
0
Association of demographic and clinical factors with change in cognitive processing speed
Query!
Assessment method [41]
0
0
Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in cognitive processing speed (measured as described above) with demographic and clinical factors.
Query!
Timepoint [41]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [42]
0
0
Longitudinal change in measure of neurocognitive executive function
Query!
Assessment method [42]
0
0
Neurocognitive executive function will be measured using the Behavioral rating inventory of executive function (BRIEF). There are age-appropriate versions: BRIEF-P for age 3 to < 6 years, BRIEF for age 6 to <19 years, and BRIEF-A for age =19 years. Executive function will also be measured using Conner's Parent Rating Scale, Third Edition (CPRS-III), for age 6 to < 19 years and also CogState, for age =5 years, One-Back and Groton Maze tasks. Linear mixed-effects models will be used to model change in executive function over time.
Query!
Timepoint [42]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [43]
0
0
Association of demographic and clinical factors with change in neurocognitive executive function
Query!
Assessment method [43]
0
0
Linear mixed-effects models and multivariate linear mixed-effects models will be used to examine change in executive function (measured as described above) with demographic and clinical factors.
Query!
Timepoint [43]
0
0
Baseline through 5 years after enrollment
Query!
Secondary outcome [44]
0
0
Change in measure of attention
Query!
Assessment method [44]
0
0
To assess the impact of a computer-based working memory intervention, relative to standard of care, on additional performance- and rater-based measure of attention. Attention will be measured using different instruments as age appropriate: Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for ages 3 to < 6 years (Digit Span Forward subtest), Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for ages 6 to < 17 years (Digit Span Forward subtest) or Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for ages =17 years (Digit Span Forward subtest). We will also use Conners' Continuous Performance Test, Kiddie Version V.5 for ages 4 to < 6 years and Conner's Continuous Performance Test, Second Edition (CPT-II) for ages =6 years, in addition to Cog Stage for children =5 years (Detection and Identification tasks). T tests will be used to compare changes in attention between the intervention and standard of care groups.
Query!
Timepoint [44]
0
0
Baseline (at 7-10 months after start of therapy) and at 3 months after baseline
Query!
Secondary outcome [45]
0
0
Change in measure of processing speed
Query!
Assessment method [45]
0
0
To assess the impact of a computer-based working memory intervention, relative to standard of care, on additional performance- and rater-based measure of processing speed. Cognitive processing speed function will be measured using the age-appropriate processing speed indices: WPPSI-IV which has two subsets: Bug Search and Cancellation, for age 3 to < 6 years; WISC-IV which has two subsets: Coding and Symbol Search subtests, for 6 to < 17 years, and WAIS-IV which has two subsets: Coding and Symbol Search subtests, for age =17 years. T tests will be used to compare changes in processing speed between the intervention and standard of care groups.
Query!
Timepoint [45]
0
0
Baseline (at 7-10 months after start of therapy) and at 3 months after baseline
Query!
Secondary outcome [46]
0
0
Change in measure of executive function ability
Query!
Assessment method [46]
0
0
To assess the impact of a computer-based working memory intervention, relative to standard of care, on additional performance- and rater-based measure of executive function. Executive function is measured as age-appropriate by the following: BRIEF-P (age 3 to <6 years), BRIEF (age 6 to <19 years) and BREIF-A (age =19 years). Connor's Parent Rating Scale, Third Edition (CPRS-III) will also be used for age 6 to <19 years, as well as CogState One-Back and Groton Maze tasks for age =5 years. T tests will be used to compare changes in executive function between the intervention and standard of care groups.
Query!
Timepoint [46]
0
0
Baseline (at 7-10 months after start of therapy) and at 3 months after baseline
Query!
Secondary outcome [47]
0
0
Change in measure of attention among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Query!
Assessment method [47]
0
0
Working memory intervention baseline=7-10 months after on treatment. Physical exercise intervention baseline=at patient enrollment. Attention will be measured using different instruments as age appropriate: Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for 3 to < 6 years (Digit Span Forward subtest), Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for 6 to < 17 years (Digit Span Forward subtest) or Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for =17 years (Digit Span Forward subtest). We will also use Conners' Continuous Performance Test, Kiddie Version V.5 for 4 to < 6 years and Conner's Continuous Performance Test, Second Edition (CPT-II) for =6 years, in addition to Cog Stage for children =5 years (Detection and Identification tasks). ANOVA will be used to compare changes in memory among the groups. In addition, T-tests will be used to compare the combined intervention group to each of the other two groups.
Query!
Timepoint [47]
0
0
Baseline and at 3 months after baseline
Query!
Secondary outcome [48]
0
0
Change in measure of processing speed among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Query!
Assessment method [48]
0
0
Working memory intervention baseline=7-10 months after on treatment. Physical exercise intervention baseline=at patient enrollment. Cognitive processing speed function will be measured using the age-appropriate processing speed indices: WPPSI-IV which has two subsets: Bug Search and Cancellation, for 3 to < 6 years; WISC-IV which has two subsets: Coding and Symbol Search subtests, for 6 to < 17 years, and WAIS-IV which has two subsets: Coding and Symbol Search subtests, for =17 years. ANOVA will be used to compare changes in processing speed among the groups. In addition, T-tests will be used to compare the combined intervention group to each of the other two groups.
Query!
Timepoint [48]
0
0
Baseline and at 3 months after baseline
Query!
Secondary outcome [49]
0
0
Change in measure of executive function among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Query!
Assessment method [49]
0
0
Working memory intervention baseline=7-10 months after on treatment. Physical exercise intervention baseline=at patient enrollment. Executive function is measured as age-appropriate by the following: BRIEF-P (3 to <6 years), BRIEF (6 to <19 years) and BREIF-A (=19 years). Connor's Parent Rating Scale, Third Edition (CPRS-III) will also be used for 6 to <19 years, as well as CogState One-Back and Groton Maze tasks for =5 years. ANOVA will be used to compare changes in executive function among the groups. In addition, T-tests will be used to compare the combined intervention group to each of the other two groups.
Query!
Timepoint [49]
0
0
Baseline and at 3 months after baseline
Query!
Secondary outcome [50]
0
0
Change in measure of attention between participants who received computer-based intervention VS. those who did not
Query!
Assessment method [50]
0
0
Attention will be measured using different instruments as age appropriate: Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) for 3 to < 6 years (Digit Span Forward subtest), Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) for 6 to < 17 years (Digit Span Forward subtest) or Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) for =17 years (Digit Span Forward subtest). We will also use Conners' Continuous Performance Test, Kiddie Version V.5 for 4 to < 6 years and Conner's Continuous Performance Test, Second Edition (CPT-II) for =6 years, in addition to Cog Stage for =5 years (Detection and Identification tasks). Differences between 6 months following assessment and immediate post-intervention testing, and difference between 6 months following assessment and pre-intervention testing, will be calculated for each subject and then group difference (intervention group vs. control group) will be examined using t-tests.
Query!
Timepoint [50]
0
0
Baseline (at 7-10 months after on treatment) through 6 months after baseline.
Query!
Secondary outcome [51]
0
0
Change in measure of working memory between participants who received computer-based intervention VS. those who did not
Query!
Assessment method [51]
0
0
To evaluate the maintenance of improvements in working memory three months following participation in the computer-based working memory intervention program. Memory will be measured using different instruments as age appropriate: CogStage for =5 years (Continuous Paired Associate Learning task), California Verbal Learning Test, Children's Version (CVLT-C) for 6 to < 17 years or California Verbal Learning Test, Second Edition (CVLT-II) for =17 years. The differences between six months following assessment and immediate post-intervention testing, as well as the difference between six months following assessment and pre-intervention testing, will be calculated for each subject and then the group difference (intervention group vs. control group) will be examined using t-tests.
Query!
Timepoint [51]
0
0
Baseline (at 7-10 months after on treatment) through 6 months after baseline.
Query!
Secondary outcome [52]
0
0
Change in measure of processing speed between participants who received computer-based intervention VS. those who did not
Query!
Assessment method [52]
0
0
To evaluate the maintenance of improvements on processing speed three months following participation in the computer-based working memory intervention program. Cognitive processing speed function will be measured using the age-appropriate processing speed indices: WPPSI-IV which has two subsets: Bug Search and Cancellation, for 3 to < 6 years; WISC-IV which has two subsets: Coding and Symbol Search subtests, for 6 to < 17 years, and WAIS-IV which has two subsets: Coding and Symbol Search subtests, for =17 years. The differences between six months following assessment and immediate post-intervention testing, as well as the difference between six months following assessment and pre-intervention testing, will be calculated for each subject and then the group difference (intervention group vs. control group) will be examined using t-tests.
Query!
Timepoint [52]
0
0
Baseline (at 7-10 months after on treatment) through 6 months after baseline.
Query!
Secondary outcome [53]
0
0
Change in measure of executive function between participants who received computer-based intervention VS. those who did not
Query!
Assessment method [53]
0
0
To evaluate the maintenance of improvements in executive function three months following participation in the computer-based working memory intervention program. Executive function is measured as age-appropriate by the following: BRIEF-P (3 to <6 years), BRIEF (6 to <19 years) and BREIF-A (=19 years). Connor's Parent Rating Scale, Third Edition (CPRS-III) will also be used for 6 to <19 years, as well as CogState One-Back and Groton Maze tasks for =5 years. The differences between six months following assessment and immediate post-intervention testing, as well as the difference between six months following assessment and pre-intervention testing, will be calculated for each subject and then the group difference (intervention group vs. control group) will be examined using t-tests.
Query!
Timepoint [53]
0
0
Baseline (at 7-10 months after on treatment) through 6 months after baseline.
Query!
Eligibility
Key inclusion criteria
INCLUSION CRITERIA
- Medulloblastoma or medulloblastoma variants including posterior fossa PNET as
documented by an institutional pathologist.
- Participant's age meets one of the following: (1) Age greater than or equal to 3 years
and less than 22 years of age at the time of diagnosis (may enroll on Strata W, S or
N), OR (2) age is greater than or equal to 22 years and less than 40 years AND patient
has SHH medulloblastoma (must enroll on Stratum S).
- No previous radiotherapy, chemotherapy or other brain tumor directed therapy other
than corticosteroid therapy and surgery.
- Patients must begin treatment as outlined in the protocol within 36 days of definitive
surgery (day of surgery is day 0; definitive surgery includes second surgeries to
resect residual tumor).
- Adequate performance status: children < 10-Lansky Score = 30; children = 10-Karnofsky
= 30 (except for posterior fossa syndrome).
- Females of child-bearing potential cannot be pregnant or breast-feeding. Female
participants > 10 years of age or post-menarche must have a negative serum or urine
pregnancy test prior to enrollment.
- Biological parent(s) of participant (child) enrolling on this protocol. These parents
will be assigned to cohort P. The exclusion criteria below do not apply to this
cohort.
EXCLUSION CRITERIA
- CNS embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for
example, patients with diagnosis of Atypical Teratoid / Rhabdoid Tumor (ATRT),
supratentorial PNET, pineoblastoma, ependymoblastoma, ETANTR are excluded.
- Research participants with other clinically significant medical disorders that could
compromise their ability to tolerate protocol therapy or would interfere with the
study procedures or results history.
Participants in the Stratum S maintenance chemotherapy portion of the study must meet the
criteria below prior to start of vismodegib therapy:
- Participants must be Stratum S (SHH)
- Participants must be skeletally mature defined as females with a bone age = 15 years
and males with a bone age = 17 years.
- Must be able to swallow pills
- BSA must be >0.67 and <2.5 m2
- Male and female participants of reproductive potential must agree to effective
contraception during and after study treatment. See Appendices I and II for further
guidance for participants receiving vismodegib
- ANC = 1000/mm^3 (after G-CSF discontinued)
- Platelets = 50,000/mm^3 (without support)
- Hgb = 8 g/dL (with or without transfusion support)
- Serum creatinine = 1.5 mg/dL
- Total bilirubin = 1.5X the institutional ULN
- SGPT (ALT) = 2.5X the institutional ULN
- SGOT (AST) = 2.5X the institutional ULN
- Alkaline Phosphatase = 1.5X the institutional ULN
- Serum albumin = 2.5 g/dL
Participants in the exercise intervention portion of the study must meet all criteria
below:
- Must be = 5 years and < 22 years at the time of enrollment
- Must have no congenital heart disease
- Must be capable of performing the exercise intervention at the time of baseline
assessment as determined by the treating physician.
Participants in the cognitive remediation intervention portion of the study must meet all
criteria below:
- Completed protocol-directed radiation therapy
- =5 years at the time of remediation intervention consent or age is greater than or
equal to 22 years and less than 40 years and patient has SHH medulloblastoma
- English as primary language and training aide who speaks English available to
participate in required sessions
- No significant cognitive impairment operationalized as either an IQ < 70 for children
with St. Jude SJMB12 study baseline testing or based on clinician judgment baseline IQ
missing
- No major sensory or motor impairment that would preclude valid cognitive testing
(e.g., unresolved posterior fossa syndrome, blindness, poorly controlled
seizures/photosensitive epilepsy, psychosis) or a major psychological condition that
would preclude completion of the intervention (e.g., significant oppositionality,
autism spectrum disorder, severe anxiety or depressive symptoms)
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
39
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/06/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2028
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
660
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Sydney Children's Hospital - Randwick
Query!
Recruitment hospital [2]
0
0
Children's Hospital at Westmead - Westmead
Query!
Recruitment hospital [3]
0
0
Queensland Children's Hospital - Brisbane
Query!
Recruitment hospital [4]
0
0
Royal Children's Hospital, Melbourne - Melbourne
Query!
Recruitment hospital [5]
0
0
Perth Children's Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
3052 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
6008 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
South Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Alberta
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
New Zealand
Query!
State/province [14]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
St. Jude Children's Research Hospital
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Genentech, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Government body
Query!
Name [2]
0
0
National Cancer Institute (NCI)
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Historically, medulloblastoma treatment has been determined by the amount of leftover disease
present after surgery, also known as clinical risk (standard vs. high risk). Recent studies
have shown that medulloblastoma is made up of distinct molecular subgroups which respond
differently to treatment. This suggests that clinical risk alone is not adequate to identify
actual risk of recurrence. In order to address this, we will stratify medulloblastoma
treatment in this phase II clinical trial based on both clinical risk (low, standard,
intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH). This
stratified clinical and molecular treatment approach will be used to evaluate the following:
- To find out if participants with low-risk WNT tumors can be treated with a lower dose of
radiation to the brain and spine, and a lower dose of the chemotherapy drug
cyclophosphamide while still achieving the same survival rate as past St. Jude studies
with fewer side effects.
- To find out if adding targeted chemotherapy after standard chemotherapy will benefit
participants with SHH positive tumors.
- To find out if adding new chemotherapy agents to the standard chemotherapy will improve
the outcome for intermediate and high risk Non-WNT Non-SHH tumors.
- To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced
dose cyclophosphamide and compare this to participants from the past St. Jude study.
All participants on this study will have surgery to remove as much of the primary tumor as
safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and
type of chemotherapy received will be determined by the participant's treatment stratum.
Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and
clinical risk.
The participant will be assigned to one of three medulloblastoma subgroups determined by
analysis of the tumor tissue for tumor biomarkers:
- WNT (Strata W): positive for WNT biomarkers
- SHH (Strata S): positive for SHH biomarkers
- Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHH
biomarkers or results are indeterminable
Participants will then be assigned to a clinical risk group (low, standard, intermediate, or
high) based on assessment of:
- How much tumor is left after surgery
- If the cancer has spread to other sites outside the brain [i.e., to the spinal cord or
within the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)]
- The appearance of the tumor cells under the microscope
- Whether or not there are chromosomal abnormalities in the tumor, and if present, what
type (also called cytogenetics analysis)
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01878617
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Amar Gajjar, MD
Query!
Address
0
0
St. Jude Children's Research Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01878617
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