A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS
- Conditions
- glioblastomagrade IV brain tumor10029211
- Registration Number
- NL-OMON39213
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
- Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV).
- The histological diagnosis must have been made after biopsy or neurosurgical tumour resection.
- Initial surgery/biopsy at diagnosis performed < 4 weeks (28 days) prior to randomization.
- Patient*s age is > 65 years.
- Patient is not deemed suitable by the treating physician to receive the standard radiotherapy regimen
- (60Gy/30 fractions over 6 weeks) in combination with temozolomide.
- ECOG performance status of 0, 1 or 2
- Patient may have received and continue to receive corticosteroids, but s/he have to be on a stable or decreasing dose for at least 14 days prior to randomization.
- Patient has not received prior chemotherapy or radiotherapy.
- Adequate hematological, renal and hepatic functions within 14 days prior to randomization
- Patients must be accessible for treatment and follow-up
- Informed consent
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment.
- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
- Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
- Patients who have had treatment with any investigational cancer drug prior to randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>overall survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>progression free survival, toxicity, quality of life</p><br>