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

Sponsor

Centre Leon Berard (Other)

Overall Status

Completed

CT.gov ID

NCT00820963

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide Radiation: hypofractionated radiation therapy Radiation: radiation therapy	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients undergo standard radiotherapy 5 days a week for 6 weeks.	Radiation: radiation therapy Patients undergo standard radiotherapy
Experimental: Arm II Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.	Radiation: hypofractionated radiation therapy Patients undergo hypofractionated radiotherapy
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.	Drug: temozolomide Given orally

Arm

Intervention/Treatment

Experimental: Arm I

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

Radiation: radiation therapy

Patients undergo standard radiotherapy

Experimental: Arm II

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

Radiation: hypofractionated radiation therapy

Patients undergo hypofractionated radiotherapy

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.

Drug: temozolomide

Given orally

Outcome Measures

Primary Outcome Measures

Duration of survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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