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Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00482677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2023-08-22

Study results available
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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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.

Conditions

Interventions

DRUG

temozolomide

Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.

GENETIC

DNA methylation analysis

A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms

PROCEDURE

quality-of-life assessment

prior to randomization until end of study

RADIATION

Radiation

Short course radiotherapy

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Trans Tasman Radiation Oncology Group

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Normand Laperriere, MD, FRCPC · Princess Margaret Hospital, Canada

  • James R. Perry, MD, FRCPC · Toronto Sunnybrook Regional Cancer Centre

  • Alba A. Brandes, MD · Ospedale Bellaria

  • Johan Menten, MD, PhD · University Hospital, Gasthuisberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-14
Primary Completion
2016-03-01
Completion
2016-08-10

Countries

  • Canada
  • Germany
  • Japan
  • Netherlands

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 NCT00482677 on ClinicalTrials.gov