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 ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case
Planning Benchmark Case
Dummy RunOutlining and planning
During AccrualIndividual Case Review
Data collectionAll patients
Dosimetry Within last 5 years
QA StreamliningPARADIGM, 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