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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

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ClinicalTrials.gov Identifier: NCT01702610
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
George Shenouda, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE August 22, 2012
First Posted Date  ICMJE October 8, 2012
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01702610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Not Provided
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Mutliforme
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
  • Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT
  • Drug: Temozolomide and Accelerated Hypofractionation RT
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2012)
40
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01702610
Other Study ID Numbers  ICMJE GEN-08-013
MGRT01:TMZ/GBM ( Other Identifier: McGill University Health Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party George Shenouda, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP