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Radiation Therapy or Temozolomide in Treating Patients With Gliomas

NCT00182819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 709

Last updated 2016-10-12

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

Conditions

Interventions

DRUG

temozolomide

Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles

RADIATION

radiation therapy

50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • British Medical Research Council

    collaborator OTHER_GOV

  • Trans Tasman Radiation Oncology Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Brigitta Baumert, MD, PhD · Maastricht University Medical Center

  • Roger Stupp, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2013-08-31
Completion
2014-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Canada
  • Egypt
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Luxembourg
  • Netherlands
  • New Zealand
  • Portugal
  • Singapore
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00182819 on ClinicalTrials.gov