{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T15:36:53Z","timestamp":1772811413524,"version":"3.50.1"},"reference-count":28,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T00:00:00Z","timestamp":1723161600000},"content-version":"unspecified","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["CDR-2018-04-ST2-004"],"award-info":[{"award-number":["CDR-2018-04-ST2-004"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100014653","name":"NIHR Manchester Biomedical Research Centre","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014653","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100014653","name":"Manchester Biomedical Research Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014653","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,7,16]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Radiotherapy improves local tumour control in patients with soft tissue sarcoma of the extremities (STSE) but it also increases the probability of long-term toxicities such as tissue fibrosis, joint stiffness and lymphoedema. The use of radiation dose and volume thresholds, called dose constraints, may potentially reduce the development of toxicities in STSE. The aim of this study is to determine predictors of radiotherapy-related side effects for STSE.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) is a multicentre observational study comprising two cohorts (PredicT A and B). PredicT A, a retrospective analysis of the UK VorteX (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00423618\">NCT00423618<\/jats:ext-link>) and IMRiS clinical trials (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02520128\">NCT02520128<\/jats:ext-link>), is aimed at deriving a statistical model for development of dose\u2013volume constraints. This model will use receiving operator characteristics and multivariate analysis to predict radiotherapy side effects and patient-reported outcomes. PredicT B, a prospective cohort study of 150 patients with STSE, is aimed at testing the validity of those dose\u2013volume constraints. PredicT B is open and planned to complete recruitment by September 2024.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>PredicT B has received ethical approval from North West - Liverpool Central Research Ethics Committee (20\/NW\/0267). Participants gave informed consent to participate in the study before taking part. We will disseminate our findings via publications, presentations, national and international conference meetings and engage with local charities.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05978024\">NCT05978024<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-083617","type":"journal-article","created":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T12:41:12Z","timestamp":1723207272000},"page":"e083617","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose\u2013volume constraints development: a study protocol"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct00423618","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02520128","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05978024","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct00423618","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02520128","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05978024","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3874-3128","authenticated-orcid":false,"given":"Rita","family":"Sim\u00f5es","sequence":"first","affiliation":[{"name":"Institute of Cancer Research, London, UK"},{"name":"Royal Marsden Hospital, London, UK"},{"name":"University College London Hospital NHS Foundation Trust, London, UK"},{"name":"National Radiotherapy Trials Quality Assurance 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