Overview

Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McGill University Health Center
McGill University Health Centre/Research Institute of the McGill University Health Centre
Treatments:
Dacarbazine
Temozolomide
Criteria
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