Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
Status:
Withdrawn
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 1
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre