Brain and Central Nervous System Tumors Clinical Trial
Official title:
Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
Verified date | July 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre Leon Berard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of survival | No |
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