{"id":186,"date":"2023-02-15T15:12:15","date_gmt":"2023-02-15T15:12:15","guid":{"rendered":"http:\/\/192.168.10.30\/?page_id=186"},"modified":"2023-03-15T17:03:08","modified_gmt":"2023-03-15T17:03:08","slug":"small","status":"publish","type":"page","link":"https:\/\/rttrialsqa.org.uk\/?page_id=186","title":{"rendered":"Small"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer \u2013 a phase III randomised multi-centre trial<\/strong><\/p>\n\n\n\n

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

SMALL is a prospective, multi-centre, randomised (1:2) phase III trial of surgery versus minimally invasive VAE of patients with small, biologically favourable screen-detected breast cancer. It incorporates an 18 month Internal Pilot Study with a QuinteT Recruitment Intervention (Information Study) to optimise recruitment, and is designed to determine whether:<\/p>\n\n\n\n

\u2022             The extent of surgical treatment can be reduced in the context of standard adjuvant radiotherapy and endocrine therapy.<\/p>\n\n\n\n

\u2022             VAE is non-inferior to conventional surgery in terms of the requirement for a second operation to achieve complete resection of the cancer.<\/p>\n\n\n\n

\u2022             There is an acceptable local recurrence risk in the VAE arm with long-term follow up.<\/p>\n\n\n\n

Patients will be recruited over a 4-year period and will be followed-up for 5 years from randomisation. Long-term follow-up information will be obtained via data linkage.<\/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>Only if change in technique noted<\/td>\n<\/tr>\n
Dummy Run<\/td><\/td>If a centre is doing partial breast and did not take part in the IMPORT trial<\/td>\n<\/tr>\n
During Accrual<\/td>Individual Case Review<\/td>\"\"<\/td>Prospective review for the first patient randomised to axillary treatment <\/td>\n<\/tr>\n
Data collection<\/td>\"\"<\/td>Prospective review for the first partial breast patient randomised to the VAE arm of the study<\/td>\n<\/tr>\n
Dosimetry <\/td><\/td>\"\"<\/td><\/td>\n<\/tr>\n
QA Streamlining<\/td><\/td>\"\"<\/td>FAST FORWARD
\nIMPORT
\n
\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n

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

Chief investigator:<\/strong> Mr Stuart McIntosh, The Patrick G Johnston Centre for Cancer Research<\/p>\n\n\n\n

RT Lead: <\/strong>Professor Charlotte Coles, University of Cambridge<\/em><\/p>\n\n\n\n

Sponsor: <\/strong>University of Birmingham SMALL@trials.bham.ac.uk<\/em><\/p>\n\n\n\n

Funder:<\/strong> National Institute for Health Research (NIHR) Health Technology Assessment Programme (project reference 17\/42\/32).<\/p>\n","protected":false},"excerpt":{"rendered":"

Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer \u2013 a phase III randomised multi-centre trial Trial summary: SMALL […]<\/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-186","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/186","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=186"}],"version-history":[{"count":2,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/186\/revisions"}],"predecessor-version":[{"id":346,"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=\/wp\/v2\/pages\/186\/revisions\/346"}],"wp:attachment":[{"href":"https:\/\/rttrialsqa.org.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}