Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)

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 giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

Conditions

• Brain and Central Nervous System Tumors

Interventions

DRUG

temozolomide

Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.

GENETIC

DNA methylation analysis

O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.

OTHER

laboratory biomarker analysis

Prognostic factor analyses

PROCEDURE

adjuvant therapy

Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.

PROCEDURE

quality-of-life assessment

Quality of Life analysis will also be used to assess neurological deterioration free progression

RADIATION

radiation therapy

Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

Sponsors & Collaborators

• NCIC Clinical Trials Group

  collaborator NETWORK

• Radiation Therapy Oncology Group

  collaborator NETWORK

• Medical Research Council

  collaborator OTHER_GOV

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Wolfgang Wick · Universitatsklinikum Heidelberg

• Warren P. Mason, MD · Princess Margaret Hospital, Canada

• Michael A. Vogelbaum, MD, PhD · The Cleveland Clinic

• S. Erridge · Medical Research Council

• Anna Nowak, MD · Sir Charles Gairdner Hospital - Nedlands

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

2007-12-31

Primary Completion

2018-09-05

Completion

2029-12-31

Countries

• United States
• Australia
• Belgium
• Canada
• France
• Germany
• Israel
• Italy
• Netherlands
• Spain
• Switzerland
• United Kingdom

Study Locations