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
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Condition or disease | Intervention/treatment | Phase |
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
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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.
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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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Canada, Quebec | |
McGill University Health Center | |
Montreal, Quebec, Canada, H3G 1A4 |
Responsible Party: | George Shenouda, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre |
ClinicalTrials.gov Identifier: | NCT01702610 |
Other Study ID Numbers: |
GEN-08-013 MGRT01:TMZ/GBM ( Other Identifier: McGill University Health Center ) |
First Posted: | October 8, 2012 Key Record Dates |
Last Update Posted: | September 28, 2016 |
Last Verified: | September 2016 |
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 Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |