Sponsor study identifier
Secondary identifiers
OTHER · McGill University Health Center
interventional
50
1 country
1
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 22, 2012
Actual (reported)October 8, 2012
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)Percent of patients completing the study treatment
To determine overall survival.
At one year
To assess toxicity of the regimen
Toxicity will be assessed and graded according to CTCAE-V3
At one year
Patient will receive two weeks of neo-adjuvant Temozolomide followed by Accelerated Hypofractionated RT for a total of 20 fractions for a total of 60Gy followed by Temozolomide for 12 cycles.
Intervention is the technique and accelerated fractionation used to treat GBM
McGill University Health Center
Montreal, Quebec, H3G 1A4, Canada
Shenouda G, Souhami L, Petrecca K, Owen S, Panet-Raymond V, Guiot MC, Corredor AG, Abdulkarim B. A Phase 2 Trial of Neoadjuvant Temozolomide Followed by Hypofractionated Accelerated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Patients With Glioblastoma. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):487-494. doi: 10.1016/j.ijrobp.2016.11.006. Epub 2016 Nov 15.
50 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2012
First Posted
October 8, 2012
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component
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Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
September 28, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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