NCT01702610

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses used in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in 4 weeks. The adjuvant component of TMZ remains unchanged from current standard practice.

Conditions

• Glioblastoma Mutliforme

Interventions

Type	Name	Description
RADIATION	IMRT Technique
RADIATION	IMRT and accelerated hypofractionation technique	Intervention is the technique and accelerated fractionation used to treat GBM
RADIATION	neo-adjuvant TMZ followed by accelerated hypofractionated EBRT	Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component
DRUG	Temozolomide and Accelerated Hypofractionation RT

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-10-08
• Last updated: 2016-09-28

Locations

1 site across 1 country: Canada