Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA) (PARADIGMA)
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|ClinicalTrials.gov Identifier: NCT03480867|
Recruitment Status : Withdrawn (competing study was opened by the surgeon after this trial was opened)
First Posted : March 29, 2018
Last Update Posted : August 14, 2019
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 chemoradiotherapy has been shown to increase survival, the majority recur at the original location.
Despite many efforts to improve the local control by improving surgical techniques, increasing the radiotherapy dose or adding newer chemotherapy agents, these attempts have failed to show a survival benefit or an improved cancer control. People who are not participating in a study are usually treated with surgery followed by radiation (6 weeks duration) together with temozolomide (chemotherapy drug) followed by temozolomide alone. For patients who receive this usual treatment approach for this cancer, about 4 out of 100 are free of cancer growth five years later. Because GBM invades the surrounding normal brain, this study is looking into the possibility of minimizing invasion by starting treatment using the combination of radiotherapy and chemotherapy prior to surgery. This approach is an experimental form of treatment and the diagnosis is based exclusively on imaging and not on histology of the tumour tissue, and there is a possibility that your tumor may not be a GB but of other origins.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme, Adult||Drug: Temozolomide Radiation: Pre-Operative Radiation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||RT 28Gy in 7 fractions with a concomitant boost of 42Gy in 7 fractions+ Temozolomide (75mg/m2) followed by surgery then Temozolomide (150-200mg/m2) q 5 days every 28 days.|
|Masking:||None (Open Label)|
|Official Title:||Pre-operative Radiation Therapy (RT) and Temozolomide (TMZ) in Patients With Newly Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)|
|Estimated Study Start Date :||March 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||November 2023|
Experimental: Pre-operative RT and TMZ
Experimental: Registered one arm study Seven days of pre-operative Radiation+Temozolomide followed by surgery plus TMZ, as adjuvant component.for six cycles.
Other Name: Surgery
Radiation: Pre-Operative Radiation
Radiation is given with Temozolomide for 7 days before surgery
- To assess toxicity of the regimen [ Time Frame: one year ]Toxicity will be assessed and graded using CTCAE V. 4.03
- Number of patients completing the study treatment [ Time Frame: one year. ]To determine the overall survival
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): NCT03480867
|Canada, Québec, Canada|
|McGill University Health Centre-Cedars Cancer Centre|
|Montréal, Québec, Canada, Canada, H4A 3J1|
|Principal Investigator:||Valerie Panet-Raymond, M.D.||McGill University Health Centre/Research Institute of the McGill University Health Centre|