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OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies
Trial summary: 2 parallel, multi-centre, open-label, non-randomised, dose-escalation phase I studies within one clinical trial protocol in newly diagnosed WHO grade 4 GBM stratified by MGMT status. Parallel I: a phase I dose escalation study in patients with methylation of the MGMT promoter region of olaparib in combination with radical radiotherapy (60 Gray in 30 fractions over 6 weeks) and concomitant temozolomide chemotherapy (75mg/m2 daily throughout radiotherapy) followed immediately by a further 4-week period of olaparib treatment. Patients will then receive adjuvant temozolomide as per standard care. Parallel II: a phase I dose escalation study in patients with unmethylated MGMT promoter regions of olaparib in combination with radical radiotherapy (60 Gray in 30 fractions over 6 weeks) followed immediately by a further 4-week period of olaparib treatment. Patients will not receive adjuvant temozolomide. There will be a dose expansion phase for each parallel group following completion of the phase I dose escalation.
RT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
QA Process | QA Activity | Required for Trial | Additional Details |
---|---|---|---|
Pre-Accrual | Facility Questionnaire | ![]() | |
Outlining Benchmark Case | |||
Planning Benchmark Case | |||
Dummy Run | Outlining and planning | ||
During Accrual | Individual Case Review | ||
Data collection | ![]() | All patients | |
Dosimetry | ![]() | Within last 5 years | |
QA Streamlining | ![]() | PARADIGM, ROAM, BRIOCHe |
RTTQA contact: paradigmqa.enh-tr@nhs.net
Chief investigator: Prof Anthony Chalmers
Sponsor: NHS Greater Glasgow & Clyde and University of Glasgow
Funder: CRUK/The Brain Tumour Charity and Astra Zeneca
CTU contact: Lorna.Sweeting@glasgow.ac.uk