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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs 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.

Official Title
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Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: temozolomide
* Radiation: hypofractionated radiation therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo standard radiotherapy 5 days a week for 6 weeks. | Radiation: radiation therapy<br>* Patients undergo standard radiotherapy<br>|
| Experimental: Arm II<br>Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks. | Radiation: hypofractionated radiation therapy<br>* Patients undergo hypofractionated radiotherapy<br>|
| Experimental: Arm III<br>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. | Drug: temozolomide<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma