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