Status:
WITHDRAWN
Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Glioblastoma Multiforme, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Glioblastoma (GBM) is the most common primary brain cancer in adults. Despite surgery, conventional radiotherapy, and chemotherapy, the average survival for GBM is 15-16 months. Although additional ch...
Detailed Description
One of the deadly properties of GBM is its capacity to diffusely infiltrate the surrounding normal brain tissue. Unlikely many malignancies, in GBM local disease progression, rather than metastatic di...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Newly diagnosed (MR image-based) GBM - Must be able to undergo gadolinium-enhanced MRI.
- Must be a candidate for radical surgical resection in the opinion of the neurosurgeon.
- The tumor must measure less than 6 cm in maximum diameter. The tumor diameter will be the greatest diameter as measured on the contrast-enhanced MRI.
- A neurosurgical oncologist, radiation oncologist and neuro-oncologist will assess each patient in advance of enrollment.
- The estimated post-surgical radiation field must be compatible with the proposed radiation scheme - ie, to ensure a safe radiation margin from structures such as the optic apparatus and brain stem.
- The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
- Age\>18years
- Karnofsky Performance Status (KPS) 70.
- History and physical examination within 14 days from start of therapy, including documentation of steroid dose.
- Adequate complete blood counts (Absolute neutrophil count (ANC) .:! 1,800. cells/mm3; Platelets.:! 100,000 cells/mm3; Hemoglobin.:! 10.0 g/dl), renal and liver function within 14 days prior to therapy with values\< 3x (upper limit normal) ULN.
- For females of child-bearing potential, negative serum pregnancy test within 14 days prior to therapy and use of contraception.
- Signed consent form.
- Exclusion Criteria:
- Tumors within 1 cm from critical structures (brainstem, optic apparatus), or with massive edema, or with the possibility of herniation, or any tumor that in the neurosurgeon's opinion would be considered unsafe to delay surgery or is not grossly resectable.
- Prior invasive malignancy (except for non-melanomatous skin cancer, non- invasive bladder cancer, and non-invasive cervix cancer) unless disease free for 2:5 years.
- Recurrent or multifocal GBM.
- Any site of metastatic disease (drop metastases).
- Prior chemotherapy or radiation therapy to the head or neck (except for T1 glottic tumor
- Severe active co-morbid medical condition as assessed by medical team.
- Patients enrolled in any other protocol.
- Inability to undergo MRI.
Exclusion
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03480867
Start Date
March 1 2017
End Date
November 1 2023
Last Update
August 14 2019
Active Locations (1)
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1
McGill University Health Centre-Cedars Cancer Centre
Montreal, Québec, Canada, Canada, H4A 3J1