Survival of patients with recurrent malignant brain tumor (glioblastoma multiforme) treated with surgical resection and local chemotherapy using impregnated wafer (Gliadel® ) in relation to a clinical predictor; the methylation of methylguanin-DNA-methyltransferase (MGMT) promotor
Not Applicable
Completed
- Conditions
- Recurrent glioblastoma multiforme WHO IV, primary treated by surgical resection and radiochemotherapy.CancerGlioblastoma Multiforme
- Registration Number
- ISRCTN15192099
- Lead Sponsor
- nfallkrankenhaus Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. First recurrent manifestation of a glioblastoma multiforme
2. Female and male =18 years
3. Previous adjuvant radio-chemotherapy chemotherapy in accordance with the ”Stupp protocol
4. The indication for revision surgery follows the usual balancing of risks and benefits of the therapy, informed consent and –finally- decision of the patient
Exclusion Criteria
1. Patients who underwent more than one surgical revision of malignant glioma
2. Previous implantation of carmustine wafer (Giadel ®)
3. More than six cycles of the Stupp scheme (radio-chemotherapy)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (measured by the date of resection and carmustine wafer implantation and time of death) in relation to the methylation of the MGMT promoter
- Secondary Outcome Measures
Name Time Method <br> 1. Progression free survival after first revision surgery measured by the recurrence criteria (MacDonald) in cerebral CT and MRI scans in follow-up visits at 3, 6 and 12 months<br> 2. Quality of Life (generic: Short-Form [SF] 36) at one year of follow-up<br> 3. Complication rates (edema, infections, bleeding, surgical revisions for all causes, serious adverse events [SAE]) throughout the study<br>