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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/NCT00085735
Registration number
NCT00085735
Ethics application status
Date submitted
14/06/2004
Date registered
16/06/2004
Date last updated
11/10/2023
Titles & IDs
Public title
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
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Scientific title
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
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Secondary ID [1]
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NCI-2009-00335
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Secondary ID [2]
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ACNS0331
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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:
Untreated Childhood 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: Drugs - Cisplatin
Treatment: Other - Craniospinal Irradiation
Treatment: Drugs - Cyclophosphamide
Treatment: Other - Involved-Field Radiation Therapy
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Lomustine
Other interventions - Quality-of-Life Assessment
Treatment: Other - Radiation Therapy
Treatment: Drugs - Vincristine Sulfate
Experimental: Arm I (3-7 years of age, LDCSI, IFRT) - See Detailed Description (Arm I)
Experimental: Arm II (3-7 years of age, LDCSI, PFRT) - See Detailed Description (Arm II)
Experimental: Arm III (3-7 years of age, SDCSI, IFRT) - See Detailed Description (Arm III)
Active Comparator: Arm IV (3-7 years of age, SDCSI, PFRT) - See Detailed Description (Arm IV)
Experimental: Arm V (8-21 years of age, SDCSI, IFRT) - See Detailed Description (Arm V)
Active Comparator: Arm VI (8-21 years of age, SDCSI, PFRT) - See Detailed Description (Arm VI)
Treatment: Drugs: Cisplatin
Given IV
Treatment: Other: Craniospinal Irradiation
Undergo craniospinal Irradiation
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Other: Involved-Field Radiation Therapy
Undergo smaller volume boost (involved-field radiation therapy)
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Lomustine
Given orally
Other interventions: Quality-of-Life Assessment
Ancillary studies
Treatment: Other: Radiation Therapy
Undergo standard volume boost (whole posterior fossa radiation therapy)
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Event-free Survival (EFS)
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Assessment method [1]
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EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).
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Timepoint [1]
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Assessed at 3 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]).
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Timepoint [2]
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3 years
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Secondary outcome [1]
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Local Posterior Fossa (LPF) Failure Rate
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Assessment method [1]
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LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Non-local Posterior Fossa (NLPF) Failure Rate
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Assessment method [2]
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NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Non-posterior Fossa (NPF) Failure Rate
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Assessment method [3]
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NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Post-treatment Endocrine Function by CSI Group
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Assessment method [4]
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Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
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Assessment method [5]
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Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
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Assessment method [6]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
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Timepoint [6]
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4 -15 months post diagnosis
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Secondary outcome [7]
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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
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Assessment method [7]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.
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Timepoint [7]
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27 - 48 months post diagnosis
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Secondary outcome [8]
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Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
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Assessment method [8]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.
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Timepoint [8]
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49 - 72 months post diagnosis
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Secondary outcome [9]
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Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
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Assessment method [9]
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Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
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Assessment method [10]
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Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.
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Timepoint [10]
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Post-treatment up to 3 years
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Secondary outcome [11]
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Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
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Assessment method [11]
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OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
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Timepoint [11]
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3 years
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Secondary outcome [12]
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Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
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Assessment method [12]
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PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.
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Timepoint [12]
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3 years
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Secondary outcome [13]
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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)
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Assessment method [13]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
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Timepoint [13]
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4 - 15 months post diagnosis
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Secondary outcome [14]
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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)
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Assessment method [14]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
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Timepoint [14]
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27-48 months post diagnosis
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Secondary outcome [15]
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Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
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Assessment method [15]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.
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Timepoint [15]
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49 - 72 months post diagnosis
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Secondary outcome [16]
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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
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Assessment method [16]
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Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis.
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Timepoint [16]
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4-15 months post diagnosis
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Secondary outcome [17]
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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
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Assessment method [17]
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Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis.
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Timepoint [17]
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27-48 months post diagnosis
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Secondary outcome [18]
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Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
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Assessment method [18]
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Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis.
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Timepoint [18]
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49 - 72 months post diagnosis
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Eligibility
Key inclusion criteria
- Histologically confirmed medulloblastoma located in the posterior fossa
- Standard-risk disease
- Minimal volume, non-disseminated disease, defined by the following:
- Residual tumor = 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days
after surgery
- No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed
by both of the following:
- Enhanced MRI of the spine within 5 days before surgery OR within 28 days
after surgery
- Negative cytological examination of CSF after surgery, but before study
enrollment
- Brain stem involvement allowed
- Performance status - Karnofsky 50-100% (> 16 years of age)
- Performance status - Lansky 30-100% (= 16 years of age)
- Absolute neutrophil count > 1,500/uL
- Platelet count > 100,000/uL (transfusion independent)
- Hemoglobin > 10 g/dL (transfusions allowed)
- Bilirubin < 1.5 times upper limit of normal (ULN) for age
- AST or ALT < 1.5 times ULN for age
- Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min/1.73m^2
or a serum creatinine based on age/gender as follows:
Age Maximum Serum Creatine (mg/dL)
- 1month to < 6 months male: 0.4 female: 0.4
- 6 months to <1 year male: 0.5 female: 0.5
- 1 year to < 2 years male: 0.6 female: 0.6
- 2 to < 6 years male: 0.8 female: 0.8
- 6 to < 10 years male: 1 female: 1
- 10 to < 13 years male: 1.2 female: 1.2
- 13 to < 16 years male: 1.5 female: 1.4
- >= 16 years male: 1.7 female: 1.4
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy
- Prior corticosteroids allowed
- No prior radiotherapy
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Minimum age
3
Years
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
549
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Iowa
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Kentucky
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Louisiana
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Tennessee
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British Columbia
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Canada
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Manitoba
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Canada
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Den Haag
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Auckland
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Christchurch
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Switzerland
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Bern
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Geneva
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Switzerland
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State/province [60]
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying how well standard-dose radiation therapy works
compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard
volume boost radiation therapy works compared to smaller volume boost radiation therapy when
given together with chemotherapy in treating young patients who have undergone surgery for
newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to
damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine,
and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop
growing or die. Giving radiation therapy with chemotherapy after surgery may kill any
remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more
effective than reduced-dose radiation therapy when given together with chemotherapy after
surgery in treating young patients with medulloblastoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00085735
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Jeff Michalski
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Children's Oncology Group
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00085735
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