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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/NCT00602667
Registration number
NCT00602667
Ethics application status
Date submitted
10/01/2008
Date registered
28/01/2008
Date last updated
11/04/2024
Titles & IDs
Public title
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
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Scientific title
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
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Secondary ID [1]
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R01CA154619
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Secondary ID [2]
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SJYC07
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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:
Brain and Central Nervous System Tumors
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Induction Chemotherapy
Treatment: Drugs - Low-Risk Therapy
Treatment: Drugs - High-Risk Therapy
Treatment: Drugs - Intermediate-Risk Therapy
Experimental: Low-Risk Patients - Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
Note: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.
Experimental: High-Risk Patients - Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.
Experimental: Intermediate-Risk Therapy - Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
Treatment: Drugs: Induction Chemotherapy
All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.
Treatment: Drugs: Low-Risk Therapy
Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
Treatment: Drugs: High-Risk Therapy
High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
Treatment: Drugs: Intermediate-Risk Therapy
Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan.
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Intervention code [1]
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Treatment: Drugs
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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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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
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Assessment method [1]
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Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.
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Timepoint [1]
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From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
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Primary outcome [2]
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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
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Assessment method [2]
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Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.
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Timepoint [2]
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From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
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Primary outcome [3]
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Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
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Assessment method [3]
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Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.
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Timepoint [3]
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From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after
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Secondary outcome [1]
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Number of Participants With Chromosomal Abnormalities
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Assessment method [1]
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Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values.
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Timepoint [1]
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Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
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Secondary outcome [2]
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Numbers of Patients With Gene Alterations
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Assessment method [2]
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Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table.
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Timepoint [2]
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Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
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Secondary outcome [3]
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Numbers of Patients With Molecular Abnormalities by Tumor Type
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Assessment method [3]
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Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values.
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Timepoint [3]
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Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
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Secondary outcome [4]
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Number of Successful Collections for Frozen and Fixed Tumor Samples
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Assessment method [4]
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Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available.
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Timepoint [4]
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Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
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Secondary outcome [5]
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Event-free Survival (EFS) Compared to Historical Controls
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Assessment method [5]
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EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.
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Timepoint [5]
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From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years
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Secondary outcome [6]
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Overall Survival (OS) Compared to Historical Controls
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Assessment method [6]
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OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.
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Timepoint [6]
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1 year after treatment initiation of last patient
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Secondary outcome [7]
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Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
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Assessment method [7]
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For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response [ PR]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks.
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Timepoint [7]
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From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)
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Secondary outcome [8]
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Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
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Assessment method [8]
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For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.
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Timepoint [8]
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From on-study date up to 4 months after on-study date
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Secondary outcome [9]
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Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
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Assessment method [9]
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For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.
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Timepoint [9]
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At completion of consolidation therapy (up to 6 months after on-study date)
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Secondary outcome [10]
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Percent of Patients With Sustained Objective Responses Rate After Consolidation
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Assessment method [10]
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For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response.
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Timepoint [10]
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8 weeks after completion of consolidation therapy (up to 8 months after on-study date)
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Secondary outcome [11]
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Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
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Assessment method [11]
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These data are based on patient diaries. For children <3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.
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Timepoint [11]
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From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)
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Secondary outcome [12]
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Change in Neurostructure, Especially White Matter Volume and Integrity
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Assessment method [12]
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Quantitative MRI measures of change in neurostructure (especially white matter volume and integrity) over time will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.
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Timepoint [12]
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From baseline to 60 months off therapy
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Secondary outcome [13]
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Percent of PET Scans With Loss of Signal Intensity
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Assessment method [13]
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Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay.
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Timepoint [13]
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Up to 3 times during RT consolidation
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Secondary outcome [14]
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Concentration of Cerebrospinal Fluid Neurotransmitters
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Assessment method [14]
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Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range.
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Timepoint [14]
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Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date
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Secondary outcome [15]
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Number and Type of Genetic Polymorphisms
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Assessment method [15]
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Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280.
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Timepoint [15]
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At study enrollment (Day 0)
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Secondary outcome [16]
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Pharmacogenetic Variation on Central Nervous System Transmitters
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Assessment method [16]
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Frequencies of genetic polymorphisms were reported.
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Timepoint [16]
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At study enrollment (Day 0)
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Secondary outcome [17]
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Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe
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Assessment method [17]
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Timepoint [17]
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Baseline and up to 60 months after completion of therapy.
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Secondary outcome [18]
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Change in Quantitative MR Measures in the Right Frontal-parietal Regions
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Assessment method [18]
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Timepoint [18]
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Baseline and up to 5 years after completion of therapy
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Secondary outcome [19]
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Number of Participants With Endocrinopathy
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Assessment method [19]
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Serial GH testing (at baseline, the end of therapy, and at 6 and 24 months after completion of therapy) will be performed on consenting patients in order to estimate longitudinal change in GH secretion as measured by mean peak GH values, with the intent to explore associations with radiation dose to the hypothalamus. Since determination of proton- or photon-based radiotherapy is not based on randomization, it will not be possible to compare the endocrine outcome between the patients with and without PBT. However, the differences between these two clinical cohorts with respect to clinical and demographic variables of interest will be summarized via descriptive statistics.
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Timepoint [19]
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Baseline, end of therapy, and at 6- and 24-months after completion of therapy
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Secondary outcome [20]
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Longitudinal Change in Growth Hormone Secretion
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Assessment method [20]
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The intent of this objective is to estimate the longitudinal change in abnormal GH secretion as measured by mean peak GH values via a mixed effects model for the patients who receive PBT.
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Timepoint [20]
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Baseline, end of therapy, and at 6- and 24-months after completion of therapy
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Secondary outcome [21]
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Methotrexate Clearance in Induction Cycle 1
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Assessment method [21]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.
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Timepoint [21]
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Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)
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Secondary outcome [22]
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Methotrexate Clearance in Induction Cycle 2
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Assessment method [22]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.
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Timepoint [22]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [23]
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Methotrexate Clearance in Induction Cycle 3
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Assessment method [23]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.
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Timepoint [23]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [24]
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Methotrexate Clearance in Induction Cycle 4
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Assessment method [24]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.
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Timepoint [24]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [25]
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Methotrexate Volume of Central Compartment in Induction Cycle 1
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Assessment method [25]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.
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Timepoint [25]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [26]
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Methotrexate Volume of Central Compartment in Induction Cycle 2
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Assessment method [26]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.
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Timepoint [26]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [27]
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Methotrexate Volume of Central Compartment in Induction Cycle 3
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Assessment method [27]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.
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Timepoint [27]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [28]
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Methotrexate AUC0-66h in Induction Cycle 1
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Assessment method [28]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.
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Timepoint [28]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [29]
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Methotrexate AUC0-66h in Induction Cycle 2
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Assessment method [29]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.
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Timepoint [29]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [30]
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Methotrexate Volume of Central Compartment in Induction Cycle 4
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Assessment method [30]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.
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Timepoint [30]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [31]
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Methotrexate AUC0-66h in Induction Cycle 3
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Assessment method [31]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.
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Timepoint [31]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [32]
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Methotrexate AUC0-66h in Induction Cycle 4
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Assessment method [32]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.
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Timepoint [32]
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Pre-infusion and 6, 23, 42, 66 hours from start of MTX
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Secondary outcome [33]
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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
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Assessment method [33]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.
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Timepoint [33]
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42 hours from start of MTX
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Secondary outcome [34]
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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
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Assessment method [34]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.
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Timepoint [34]
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0
42 hours from start of MTX
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Secondary outcome [35]
0
0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
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Assessment method [35]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.
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Timepoint [35]
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0
42 hours from start of MTX
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Secondary outcome [36]
0
0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
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Assessment method [36]
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Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.
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Timepoint [36]
0
0
42 hours from start of MTX
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Secondary outcome [37]
0
0
Cyclophosphamide Clearance in Induction Chemotherapy
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Assessment method [37]
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Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.
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Timepoint [37]
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Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [38]
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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
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Assessment method [38]
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Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.
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Timepoint [38]
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0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [39]
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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
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Assessment method [39]
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Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.
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Timepoint [39]
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Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [40]
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0
Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
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Assessment method [40]
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Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.
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Timepoint [40]
0
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Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose
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Secondary outcome [41]
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0
Cyclophosphamide AUC0-24h in Induction Chemotherapy
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Assessment method [41]
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Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
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Timepoint [41]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [42]
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0
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
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Assessment method [42]
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Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
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Timepoint [42]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [43]
0
0
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
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Assessment method [43]
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4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
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Timepoint [43]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [44]
0
0
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
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Assessment method [44]
0
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Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
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Timepoint [44]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
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Secondary outcome [45]
0
0
Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
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Assessment method [45]
0
0
Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis.
Query!
Timepoint [45]
0
0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Query!
Secondary outcome [46]
0
0
4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
Query!
Assessment method [46]
0
0
4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [46]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Query!
Secondary outcome [47]
0
0
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
Query!
Assessment method [47]
0
0
4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Query!
Timepoint [47]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Query!
Secondary outcome [48]
0
0
4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
Query!
Assessment method [48]
0
0
4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [48]
0
0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Query!
Secondary outcome [49]
0
0
CEPM AUC0-24h in Induction Chemotherapy
Query!
Assessment method [49]
0
0
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [49]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Query!
Secondary outcome [50]
0
0
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
Query!
Assessment method [50]
0
0
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Query!
Timepoint [50]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Query!
Secondary outcome [51]
0
0
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
Query!
Assessment method [51]
0
0
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Query!
Timepoint [51]
0
0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Query!
Secondary outcome [52]
0
0
CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
Query!
Assessment method [52]
0
0
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [52]
0
0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Query!
Secondary outcome [53]
0
0
Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
Query!
Assessment method [53]
0
0
Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported.
Query!
Timepoint [53]
0
0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Query!
Secondary outcome [54]
0
0
Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
Query!
Assessment method [54]
0
0
Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.
Query!
Timepoint [54]
0
0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Query!
Secondary outcome [55]
0
0
Topotecan Clearance in Consolidation Chemotherapy
Query!
Assessment method [55]
0
0
Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.
Query!
Timepoint [55]
0
0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Query!
Secondary outcome [56]
0
0
Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
Query!
Assessment method [56]
0
0
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.
Query!
Timepoint [56]
0
0
Pre-dose, 0.25, 1.5 and 6 hours post-dose
Query!
Secondary outcome [57]
0
0
Topotecan AUC0-24h in Consolidation Chemotherapy
Query!
Assessment method [57]
0
0
Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Query!
Timepoint [57]
0
0
Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion
Query!
Secondary outcome [58]
0
0
Topotecan AUC0-24h in Maintenance Chemotherapy
Query!
Assessment method [58]
0
0
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
Query!
Timepoint [58]
0
0
Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose
Query!
Secondary outcome [59]
0
0
Erlotinib Apparent Oral Clearance
Query!
Assessment method [59]
0
0
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis.
Query!
Timepoint [59]
0
0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Query!
Secondary outcome [60]
0
0
Erlotinib Apparent Volume of Central Compartment
Query!
Assessment method [60]
0
0
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis.
Query!
Timepoint [60]
0
0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Query!
Secondary outcome [61]
0
0
Erlotinib AUC0-24h
Query!
Assessment method [61]
0
0
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [61]
0
0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Query!
Secondary outcome [62]
0
0
OSI-420 AUC0-24h
Query!
Assessment method [62]
0
0
Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.
Query!
Timepoint [62]
0
0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Query!
Secondary outcome [63]
0
0
Rate of Local Disease Progression
Query!
Assessment method [63]
0
0
Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.
Query!
Timepoint [63]
0
0
1 year after completion of radiation therapy for last patient
Query!
Secondary outcome [64]
0
0
Rate of Distant Disease Progression
Query!
Assessment method [64]
0
0
Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.
Query!
Timepoint [64]
0
0
1 year after completion of radiation therapy for last patient
Query!
Secondary outcome [65]
0
0
Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores
Query!
Assessment method [65]
0
0
Global cognitive functioning was measured based on Cognitive Composite Scores from the Bayley III instrument for subjects <3 years of age and on estimated IQ scores from the Stanford Binet V instrument for subjects =3 years of age. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.
Query!
Timepoint [65]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [66]
0
0
Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores
Query!
Assessment method [66]
0
0
Scores measuring attention were obtained from the Attention Problems T-score on the BASC-2 instrument which is a parent report. Higher scores indicate more attention problems. The normative mean is 50 with a standard deviation of 10.
Query!
Timepoint [66]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [67]
0
0
Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores
Query!
Assessment method [67]
0
0
Scores measuring processing speed were obtained based on the visual matching standard score from the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.
Query!
Timepoint [67]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [68]
0
0
Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores
Query!
Assessment method [68]
0
0
Scores measuring executive functioning were obtained from Global Executive Composite (GEC) T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.
Query!
Timepoint [68]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [69]
0
0
Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores
Query!
Assessment method [69]
0
0
Scores measuring working memory were obtained from Working Memory T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.
Query!
Timepoint [69]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [70]
0
0
Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores
Query!
Assessment method [70]
0
0
Scores measuring verbal fluency were obtained from Retrieval Fluency standard scores on the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.
Query!
Timepoint [70]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [71]
0
0
Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores
Query!
Assessment method [71]
0
0
Scores measuring visual-spatial reasoning were obtained from Visual Perception T-scores on the Beery Visual Motor Integration (VMI) instrument. Higher scores indicate better performance. The normative mean is 50 with a standard deviation of 10.
Query!
Timepoint [71]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Secondary outcome [72]
0
0
Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores
Query!
Assessment method [72]
0
0
Scores measuring visual-spatial reasoning were obtained from VMI T-scores on the Beery VMI instrument. Higher scores indicate better performance. The normative mean is 50 with standard deviation of 10.
Query!
Timepoint [72]
0
0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Query!
Eligibility
Key inclusion criteria
Histologically confirmed newly diagnosed CNS tumors of any of the following :
- Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic
medulloblastoma)
- Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or
ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
- Pineoblastoma
- Atypical teratoid rhabdoid tumor (ATRT)
- Choroid plexus carcinoma
- High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma,
anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features,
high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal
tumor, glioblastoma multiforme), or gliosarcoma,
- Ependymoma (including all ependymoma histological variants)
- Age < 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma
patients = 3 and < 5years old at diagnosis who have non-metastatic disease with no
more than 1cm2 of residual tumor are also eligible.
- Meets criteria for 1 of the following risk groups:
- Low-risk group:
- Histologically confirmed nodular desmoplastic medulloblastoma, including
medulloblastoma with extensive nodularity
- Focal areas of anaplasia or other atypical features suggesting more
aggressive phenotype in a tumor otherwise considered nodular desmoplastic
should be treated on the intermediate-risk group, with final risk
stratification at the discretion of principal investigator and study
pathologist
- No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic
examination of lumbar cerebrospinal fluid (CSF)
- Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1
disease when lumbar puncture is medically contraindicated
- Intermediate-risk group assignment when there is no other evidence of
metastasis and CSF sampling is not possible
- Gross total resection, defined as residual tumor or imaging abnormality (not
definitive for residual tumor) with a size of < 1 cm2 confirmed on postoperative
CT scan or MRI
- Brain stem invasion by the tumor in the absence of imaging evidence of residual
tumor (tumor size < 1 cm2) and otherwise meets criteria for the low-risk group,
the patient will be classified as low-risk
- Desmoplastic medulloblastoma patients who are =3 -<5 years of age will NOT be
eligible for the low risk arm of the protocol.
- Intermediate-risk group:
- Histologically confirmed nodular desmoplastic medulloblastoma with less than
gross total resection and no evidence of metastasis
- Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no
evidence of CNS metastasis
- Medulloblastoma patients who are =3 and < 5 yrs of age irrespective of histology
and with no evidence of CNS metastasis
- High-risk group:
- Any eligible histologic diagnosis with evidence of CNS metastasis
- Patients with extraneural metastasis are eligible for treatment on the high-risk
group
PATIENT CHARACTERISTICS:
- Lansky performance status = 30 (except for posterior fossa syndrome)
- WBC > 2,000/mm3
- Platelets > 50,000/mm3 (without support)
- Hemoglobin > 8 g/dL (with or without support)
- ANC > 500/mm3
- Serum creatinine < 3 times upper limit of normal (ULN)
- ALT < 5 times ULN
- Total bilirubin < 3 times ULN
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 31 days since prior definitive surgery
- No prior radiotherapy or chemotherapy other than corticosteroid therapy
Query!
Minimum age
No limit
Query!
Query!
Maximum age
5
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
17/12/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
293
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Lady Cilento Children's Hospital, Brisbane - Brisbane
Query!
Recruitment postcode(s) [1]
0
0
4029 - Brisbane
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
Minnesota
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Tennessee
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Texas
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
Other
Query!
Name [1]
0
0
University of Florida
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!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
The Pew Charitable Trusts
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat
brain tumors in young children. Using chemotherapy gives the brain more time to develop
before radiation is given. The chemotherapy in this study includes the drug methotrexate.
This drug was an important part of the two clinical trials which resulted in the best
survival results for children less than 3 years of age with medulloblastoma. Most patients
treated on this trial will also receive radiation which is carefully targeted to the area of
the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in
fewer problems with thinking and learning than radiation to the whole brain and spinal cord.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together
with radiation therapy works in treating young patients with newly diagnosed central nervous
system tumors.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00602667
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/NCT00602667
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