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Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

NCT00085098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-07

Study results available
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Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor.

PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.

Conditions

Interventions

BIOLOGICAL

filgrastim

Given by infusion or injection

DRUG

carboplatin

Given IV over 1 hour

DRUG

cisplatin

Given IV over 6 hours

DRUG

cyclophosphamide

Given IV over 1 hour

DRUG

etoposide

Given IV over 2 hours

RADIATION

radiation therapy

Patients undergo radiotherapy 5 days a week

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Jeffrey C. Allen, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • Australia
  • Canada
  • Puerto Rico

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 NCT00085098 on ClinicalTrials.gov