Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Completed · Phase 3

Conditions studied: Medulloblastoma

In brief

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.

Key facts

Study ID

NCT00085735

Run by

Children's Oncology Group

People needed

549

Starts

2004-04-30

Expected to finish

2024-12-31

Last updated by the study team

2026-06-09

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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