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Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme

Study Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. 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 standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme. PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed glioblastoma multiforme.
  • - Grade 4 disease (WHO) PATIENT CHARACTERISTICS: - WHO performance status (PS) 0-2 (PS 3-4 allowed if secondary to a neurological physical handicap) - Life expectancy ≥ 3 months.
  • - ANC ≥ 1,500/mm^3.
  • - Platelet count ≥ 100,000/mm^3.
  • - Hemoglobin ≥ 10 g/dL.
  • - Bilirubin < 1.5 times upper limit of normal (ULN) - Transaminases ≤ 3 times ULN.
  • - Creatinine < 1.5 times ULN.
  • - Able to tolerate the 3 treatment options.
  • - No other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin.
  • - No acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study.
PRIOR CONCURRENT THERAPY:
  • - No prior chemotherapy, radiotherapy, or immunotherapy.
- Concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00820963
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Leon Berard
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Didier Frappaz, MD
Principal Investigator Affiliation Centre Leon Berard
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES: Primary.

  • - Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs.#46;hypofractionated radiotherapy vs.#46;chemotherapy.
Secondary.
  • - Compare the quality of life (QLQ-C30) of these patients.
  • - Compare the safety, tolerance, and toxicity of these regimens.
  • - Assess the pharmacoeconomic cost of these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
  • - Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.
  • - Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
  • - Arm III: Patients receive oral temozolomide on days 1-5.
Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Arms & Interventions

Arms

Experimental: Arm I

Patients undergo standard radiotherapy 5 days a week for 6 weeks.

Experimental: Arm II

Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.

Experimental: Arm III

Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Interventions

Drug: - temozolomide

Given orally

Radiation: - hypofractionated radiation therapy

Patients undergo hypofractionated radiotherapy

Radiation: - radiation therapy

Patients undergo standard radiotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Leon Berard, Lyon, France

Status

Address

Centre Leon Berard

Lyon, , 69373

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