drugset / Trial / NCT00003573

Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma

NCT00003573 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.

Timeline

Start
1998-11
Primary completion
2007-10
Completion
2008-03

Outcome

Missed primary endpoint

paper CONCLUSION: Five-year EFS did not differ significantly whether, after surgery, patients received chemotherapy before or after radiotherapy. PMID 23857975 ↗

paper Five-year EFS was 66.0% in the CT1 arm and 70.0% in the RT1 arm (P = .54) PMID 23857975 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — Intravenous
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Etoposide Small molecule 35 mg/m2 Oral
Subject Etoposide Small molecule 50 mg/m2 Oral
Subject Vincristine Small molecule — Intravenous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications