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18 Years
Open (Enrolling)
Glioblastoma Mutliforme

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Trial Information

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of patients completing the study treatment

Outcome Description:

To determine overall survival.

Outcome Time Frame:

At one year

Safety Issue:



Canada: Health Canada Therapeutic Products Directorate

Study ID:




Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Mutliforme
  • Glioblastoma