{"id":198,"date":"2023-02-15T15:44:03","date_gmt":"2023-02-15T15:44:03","guid":{"rendered":"http:\/\/192.168.10.30\/?page_id=198"},"modified":"2023-02-15T15:44:03","modified_gmt":"2023-02-15T15:44:03","slug":"paradigm-2","status":"publish","type":"page","link":"https:\/\/rttrialsqa.org.uk\/?page_id=198","title":{"rendered":"Paradigm-2"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies<\/p>\n\n\n\n

Trial summary:<\/strong> 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.<\/p>\n\n\n\n

RT QA summary:<\/h2>\n\n\n\n

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.<\/em><\/p>\n\n\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
QA Process<\/th>QA Activity<\/th>Required for Trial<\/th>Additional Details<\/th>\n<\/tr>\n<\/thead>\n
Pre-Accrual<\/td>Facility Questionnaire<\/td>\"\"<\/td><\/td>\n<\/tr>\n
Outlining Benchmark Case<\/td><\/td><\/td>\n<\/tr>\n
Planning Benchmark Case<\/td><\/td><\/td>\n<\/tr>\n
Dummy Run<\/td><\/td>Outlining and planning<\/td>\n<\/tr>\n
During Accrual<\/td>Individual Case Review<\/td><\/td><\/td>\n<\/tr>\n
Data collection<\/td>\"\"<\/td>All patients<\/td>\n<\/tr>\n
Dosimetry <\/td><\/td>\"\"<\/td>Within last 5 years<\/td>\n<\/tr>\n
QA Streamlining<\/td><\/td>\"\"<\/td>PARADIGM, ROAM, BRIOCHe<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n

RTTQA contact: <\/strong>paradigmqa.enh-tr@nhs.net <\/p>\n\n\n\n

Chief investigator: <\/strong>Prof Anthony Chalmers<\/p>\n\n\n\n

Sponsor:<\/strong> NHS Greater Glasgow & Clyde and University of Glasgow<\/p>\n\n\n\n

Funder: <\/strong>CRUK\/The Brain Tumour Charity and Astra Zeneca<\/p>\n\n\n\n

CTU contact: <\/strong>Lorna.Sweeting@glasgow.ac.uk<\/p>\n","protected":false},"excerpt":{"rendered":"

OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-198","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/198","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=198"}],"version-history":[{"count":1,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/198\/revisions"}],"predecessor-version":[{"id":200,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/198\/revisions\/200"}],"wp:attachment":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=198"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}