Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
60 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Duration of survival
Safety Issue:
No
Principal Investigator
Didier Frappaz, MD
Investigator Affiliation:
Centre Leon Berard
Authority:
United States: Federal Government
Study ID:
CDR0000626713
NCT ID:
NCT00820963
Start Date:
July 2006
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult giant cell glioblastoma
- adult glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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