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Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

NCT00002875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2014-08-01

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective when combined with radiation therapy for treating medulloblastoma.

PURPOSE: Randomized phase III trial to compare two combination chemotherapy treatments plus radiation therapy in treating children with newly diagnosed medulloblastoma.

Conditions

Interventions

BIOLOGICAL

filgrastim

DRUG

cisplatin

DRUG

cyclophosphamide

DRUG

lomustine

DRUG

mesna

DRUG

vincristine sulfate

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Pediatric Oncology Group

    collaborator OTHER

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Roger J. Packer, MD · Children's National Research Institute

  • Amar Gajjar, MD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
3 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-12-31
Primary Completion
2006-02-28
Completion
2011-01-31

Countries

  • United States
  • Australia
  • Canada
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002875 on ClinicalTrials.gov