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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702610
First Posted: October 8, 2012
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George Shenouda, McGill University Health Center
  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.

Condition Intervention
Glioblastoma Mutliforme Radiation: IMRT Technique Radiation: IMRT and accelerated hypofractionation technique Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT Drug: Temozolomide and Accelerated Hypofractionation RT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by George Shenouda, McGill University Health Center:

Primary Outcome Measures:
  • Percent of patients completing the study treatment [ Time Frame: At one year ]
    To determine overall survival.

  • To assess toxicity of the regimen [ Time Frame: At one year ]
    Toxicity will be assessed and graded according to CTCAE-V3


Enrollment: 50
Study Start Date: December 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702610


Locations
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
  More Information

Responsible Party: George Shenouda, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01702610     History of Changes
Other Study ID Numbers: GEN-08-013
MGRT01:TMZ/GBM ( Other Identifier: McGill University Health Center )
First Submitted: August 22, 2012
First Posted: October 8, 2012
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents