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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01702610
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Mutliforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: Temozolomide, Accelerated Hypofractionated RT

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

McGill University Health Center, Montreal, Quebec, Canada

Status

Address

McGill University Health Center

Montreal, Quebec, H3G 1A4

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