Glioblastoma Mutliforme Clinical Trial
Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age: 18 years or older - Histological confirmation of supratentorial GBM - KPS > 60 - Neurological function 0 or 1 - Adequate bone marrow as defined below: - absolute neutrophil count (ANC) > 1500 cells/mm3 - platelets > 100,000 cells/mm3 - hemoglobin > 10g/dl - Adequate renal function as defined below: - BUN < 25mg/dl within 14 days prior to study registration - creatinine of 63 to 103 umol/L within 14 days prior to study registration - Adequate hepatic function as defined below: - Bilirubin of 3 to 21 umol/L within 14 days prior to study registration - ALT & AST < 3xnormal range within 14 days prior to study registration - Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed feasible - A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively. - History, physical and neurological examination within 14 days prior to study registration. - For females of child-bearing potential, negative pregnancy test within 72 hours prior to starting TMZ. - Able to sign an informed study-specific consent Exclusion Criteria: - Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves. - Prior invasive malignancy, unless disease-free for >3years - Recurrent or multifocal GBM - Severe co-morbidities such as - unstable angina - transmural myocardial infarction within 6 months - COPD at the time of registration - Hepatic insufficiency - Bacterial or fungal infection requiring IV antibiotics at the time of registration - Acquired Immune Deficiency Syndrome (AIDS) - Major medical illnesses or psychiatric impairments - Pregnant women or lactating women |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | McGill University Health Center | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| McGill University Health Center |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent of patients completing the study treatment | To determine overall survival. | At one year | No |
| Primary | To assess toxicity of the regimen | Toxicity will be assessed and graded according to CTCAE-V3 | At one year | Yes |