Completed

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

What is being tested

IMRT Technique

+ IMRT and accelerated hypofractionation technique

+ neo-adjuvant TMZ followed by accelerated hypofractionated EBRT

RadiationDrug

Who is being recruted

Over 18 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: December 2008

See protocol details

Summary

Principal SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Last updated: September 28, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2008

Actual date on which the first participant was enrolled.

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.

NCT01702610

Principal SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Last updated: September 28, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

19 inclusion criteria required to participate

A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively

ALT & AST < 3xnormal range within 14 days prior to study registration

Able to sign an informed study-specific consent

Adequate bone marrow as defined below

Show More Criteria

12 exclusion criteria prevent from participating

Acquired Immune Deficiency Syndrome (AIDS)

Bacterial or fungal infection requiring IV antibiotics at the time of registration

COPD at the time of registration

Hepatic insufficiency

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

McGill University Health Center

Montreal, CanadaOpen McGill University Health Center in Google Maps

CompletedOne Study Center