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Radiation + Chemotherapy for Medulloblastoma

Phase 3
Waitlist Available
Led By Jeff Michalski
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior radiotherapy
Histologically confirmed medulloblastoma located in the posterior fossa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial is looking at whether standard-dose radiation therapy, versus reduced-dose, is more effective in children 3-7 years of age who have had surgery for newly diagnosed standard-risk medulloblastoma.

Who is the study for?
This trial is for young patients aged 3-7 with newly diagnosed standard-risk medulloblastoma, a type of brain tumor. They should have had surgery but no prior chemotherapy or radiotherapy, and their cancer shouldn't have spread. Their blood counts and organ functions need to meet specific criteria, they can't be pregnant or nursing, and must use effective contraception if applicable.
What is being tested?
The study compares different radiation therapy doses and volumes when combined with chemotherapy drugs like vincristine sulfate, lomustine, cisplatin, and cyclophosphamide after surgery in these children. It aims to find out which radiation strategy works best at killing remaining tumor cells without causing unnecessary harm.
What are the potential side effects?
Possible side effects include damage to healthy tissue from radiation, hair loss where the body is irradiated, fatigue from both treatments; nausea/vomiting due to chemo; increased risk of infections; bleeding issues related to low blood cell counts; kidney/liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had any radiotherapy treatments before.
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My cancer, medulloblastoma, is confirmed and located in the back of my brain.
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I can perform most of my daily activities without help.
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My bilirubin levels are within normal range for my age.
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My liver enzymes are within normal limits for my age.
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My kidney function is normal or near normal.
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I have never received chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free Survival (EFS)
Overall Survival (OS)
Secondary study objectives
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
+15 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Arm V (8-21 years of age, SDCSI, IFRT)Experimental Treatment8 Interventions
See Detailed Description (Arm V)
Group II: Arm III (3-7 years of age, SDCSI, IFRT)Experimental Treatment8 Interventions
See Detailed Description (Arm III)
Group III: Arm II (3-7 years of age, LDCSI, PFRT)Experimental Treatment8 Interventions
See Detailed Description (Arm II)
Group IV: Arm I (3-7 years of age, LDCSI, IFRT)Experimental Treatment8 Interventions
See Detailed Description (Arm I)
Group V: Arm IV (3-7 years of age, SDCSI, PFRT)Active Control7 Interventions
See Detailed Description (Arm IV)
Group VI: Arm VI (8-21 years of age, SDCSI, PFRT)Active Control8 Interventions
See Detailed Description (Arm VI)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~2360
Involved-Field Radiation Therapy
2002
Completed Phase 3
~1740
Lomustine
2008
Completed Phase 3
~1540
Radiation Therapy
2017
Completed Phase 3
~7250
Vincristine Sulfate
2005
Completed Phase 3
~10270
Cyclophosphamide
2010
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,281 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,211 Patients Enrolled for Medulloblastoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,451 Total Patients Enrolled
89 Trials studying Medulloblastoma
9,792 Patients Enrolled for Medulloblastoma
Jeff MichalskiPrincipal InvestigatorChildren's Oncology Group

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00085735 — Phase 3
Medulloblastoma Research Study Groups: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
Medulloblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT00085735 — Phase 3
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00085735 — Phase 3
~26 spots leftby Sep 2025
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