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Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma

NCT00003375 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2024-07-09

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. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma.

PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma.

Conditions

Interventions

DRUG

lomustine

DRUG

procarbazine hydrochloride

DRUG

vincristine sulfate

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Edward G. Shaw, MD · Wake Forest University Health Sciences

  • Geoffrey R. Barger, MD · Barbara Ann Karmanos Cancer Institute

  • Jan C. Buckner, MD · Mayo Clinic

  • Minesh P. Mehta, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-31
Primary Completion
2005-08-31
Completion
2018-05-14

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Entities

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 NCT00003375 on ClinicalTrials.gov