OlaPArib And RADiotherapy In newly-diagnosed GlioblastoMa: Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose escalation study

Trial summary: A phase I dose escalation trial followed by a phase II randomised, double blind trial of radiotherapy plus placebo versus radiotherapy plus olaparib for newly diagnosed GBM patients in whose tumours the MGMT promoter region is unmethylated and who would not be eligible for treatment with standard radical radiotherapy with concomitant and adjuvant temozolomide. Phase I aims to establish the maximum tolerated dose of olaparib when given in combination with radiotherapy. Phase II aims to obtain evidence that adding olaparib to radiotherapy improves overall survival in patients. It has an embedded dose escalation substudy of olaparib and temozolomide plus radiotherapy to establish the maximum tolerated dose of olaparib when given in combination with radiotherapy and temozolomide in patients in whose tumours the MGMT promoter region is methylated.

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			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 and Astra Zeneca

CTU contact: Lorna.Sweeting@glasgow.ac.uk