Summary
This trial is designed to efficiently evaluate therapies, and is being conducted under a single Master Protocol which allows multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.
The trial is recruiting people with either newly diagnosed glioblastoma (GBM) or recurrent GBM, inclusive of gliosarcoma. The treatment you will receive depends on which arm you are assigned to, but may include systemic therapies such as chemotherapy and targeted therapty, or radiation therapy.
This is a complex trial, please speak to your doctor or contact one of the recruiting hospitals to find out more information.
The process for therapy (treatment) evaluation
The evaluation of each therapy in this trial proceeds in 2 possible stages. A therapy's Stage 1 is an adaptively randomised Screening stage for evaluating the therapy within patient signatures compared against a common control. A therapy in Stage 1 will stop accruing patients if it reaches its maximal sample size, drops for futility or evinces inadequate safety. If a therapy reaches an efficacy threshold for graduation from Stage 1, it will move into Stage 2 within one of the prospectively defined signatures. The maximum sample size in Stage 1 is 150 patients.
For a therapy graduating to Stage 2 there is a fixed randomisation, expansion cohort. The maximum sample size in Stage 2 is 50 experimental patients in the graduating signature. The primary analysis of a regimen's effect on overally survival uses patients in both its stages and all control patients in the trial in graduating signature, suitably adjusted for any possible time treands.