{"id":277,"date":"2023-02-24T10:48:26","date_gmt":"2023-02-24T10:48:26","guid":{"rendered":"http:\/\/192.168.10.30\/?page_id=277"},"modified":"2023-02-24T10:48:26","modified_gmt":"2023-02-24T10:48:26","slug":"primert","status":"publish","type":"page","link":"https:\/\/rttrialsqa.org.uk\/?page_id=277","title":{"rendered":"PrimeRT"},"content":{"rendered":"\n

Priming the Tumour MicroEnvironment for Effective Treatment with Immunotherapy in Locally Advanced Rectal Cancer. A Phase II trial of Durvulamab (MEDI 4736) in Combination with Extended Neoadjuvant Regimens in Rectal Cancer<\/p>\n\n\n\n

Trial summary:<\/h2>\n\n\n\n

In rectal cancer, strategies to enhance local treatment responses by expanding neoadjuvant regimens are sought to enable organ preservation in more patients. The addition of systemic FOLFOX post-chemoradiotherapy and post short course radiotherapy has been reported with encouraging results demonstrating higher rates of complete response than with radiotherapy based treatment alone. Immunotherapy using PD-1\/ PD-L1 inhibition is recognised to be effective in mismatch repair deficient colorectal cancer (dMMR)… At baseline few rectal tumours (10-20%) demonstrate moderate-high grade CD3+ responses within the tumour microenvironment but there is evidence radiotherapy (e.g. SCRT or CRT) and systemic chemotherapy (FOLFOX) induce favourable immune responses. We plan a phase II trial to evaluate the potential treatment efficacy of anti-PD-L1, Durvalumab in addition to either SCRT or CRT with FOLFOX in the gap to post treatment assessment.<\/p>\n\n\n\n

This trial will evaluate rates of complete response in each arm as it\u2019s primary endpoint in addition to safety and toxicity as secondary endpoints. It is a translationally rich trial which involves the collection of biospecimens prior to, during and following treatment in order to understand the molecular and immunological factors underpinning treatment response.<\/p>\n\n\n\n

This is a phase II, 1:1 randomised trial with a safety lead-in.<\/strong><\/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><\/td>\n<\/tr>\n
During Accrual<\/td>Individual Case Review<\/td>\"\"<\/td>Of at least the first patient case<\/td>\n<\/tr>\n
Data collection<\/td>\"\"<\/td>Anonymised: PAF, brief clinical history, diagnostic imaging reports, planning CT, structures, plan and plan dose cube<\/td>\n<\/tr>\n
Dosimetry <\/td><\/td>\"\"<\/td><\/td>\n<\/tr>\n
QA Streamlining<\/td><\/td>\"\"<\/td>All other current lower GI trials considered, discuss with the RTTQA contact<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n

RTTQA contact:<\/strong> PrimeRT.RTTQA@wales.nhs.uk<\/a> <\/p>\n\n\n\n

Chief investigator: <\/strong>Mr Campbell Roxburgh, Consultant Colorectal Surgeon<\/p>\n\n\n\n

RT Lead:<\/strong> Professor Richard Adams, Consultant Clinical Oncologist<\/p>\n\n\n\n

Trials Unit:<\/strong> Cancer Research UK Clinical Trials Unit, The Beatson West of Scotland Cancer Centre; liz-anne.lewsley@glasgow.ac.uk<\/a><\/p>\n\n\n\n

Sponsor:<\/strong> NHS Greater Glasgow and Clyde\/University of Glasgow (GN18ON303)<\/p>\n\n\n\n

Funder:<\/strong> AstraZeneca<\/p>\n","protected":false},"excerpt":{"rendered":"

Priming the Tumour MicroEnvironment for Effective Treatment with Immunotherapy in Locally Advanced Rectal Cancer. A Phase II trial of Durvulamab (MEDI 4736) […]<\/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-277","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/277","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=277"}],"version-history":[{"count":1,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/277\/revisions"}],"predecessor-version":[{"id":278,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/277\/revisions\/278"}],"wp:attachment":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=277"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}