Status:
COMPLETED
Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme
Lead Sponsor:
Centre Leon Berard
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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. ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00820963
Start Date
July 1 2006
Last Update
May 12 2011
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69373