{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T04:04:54Z","timestamp":1743998694513,"version":"3.40.3"},"reference-count":8,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T00:00:00Z","timestamp":1743984000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T00:00:00Z","timestamp":1743984000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Ontario Institute of Clinical Research","award":["Clinician-Scientist Grant"],"award-info":[{"award-number":["Clinician-Scientist Grant"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Palliat Care"],"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Patients with incurable but not-yet-biopsied cancers sometimes require urgent palliative radiation. However, wait-times for biopsy procedures and pathologic results can delay treatment, with significant consequences to patient quality of life and\/or the chance of irreversible cancer complications. There is no prospective data to guide empirical decision-making in these urgent, palliative contexts.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>In this prospective single-arm pragmatic clinical trial, we will enrol 48 patients with incurable cancer where a biopsy is delaying urgent palliative radiation. Patients will receive empiric upfront palliative radiation without biopsy-confirmation. The primary endpoint is the rate of inappropriate radiation, defined when the patient\u2019s biopsy shows a non-malignant entity or a malignancy that is better treated upfront with systemic therapy (or therapy other than radiation). Secondary endpoints include: histologic diagnostic accuracy, molecular testing accuracy, biopsy complications rates, evidence of radiation effect in biopsy, time from enrolment to radiation\/biopsy, and Edmonton Symptom Assessment Scale (ESAS) scores. Patients are eligible only if the probability of incurable malignancy is deemed\u2009&gt;\u200995% and the risk of lymphoma\u2009&lt;\u200920% by the treating physician, based on clinical examination and imaging investigations.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>This study will provide prospective data to guide oncologists and patients in making informed decisions when weighing the competing risks of delaying palliative radiation versus treating without pathologic confirmation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>\n              <jats:italic>ClinicalTrials.gov<\/jats:italic> Identifier: NCT06156800. Date of registration: December 5, 2023.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s12904-025-01724-3","type":"journal-article","created":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T02:56:23Z","timestamp":1743994583000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Radiation-before-pathology approach in the palliative oncology setting: a pragmatic clinical trial protocol (RT-NOW)"],"prefix":"10.1186","volume":"24","author":[{"given":"Sympascho","family":"Young","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa","family":"O\u2019Neil","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanna M.","family":"Laba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy K.","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"X. Melody","family":"Qu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher D.","family":"Goodman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Glenn S.","family":"Bauman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Warner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Cecchini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David A.","family":"Palma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,4,7]]},"reference":[{"key":"1724_CR1","doi-asserted-by":"crossref","unstructured":"Gagliardi AR, Yip CYY, Irish J, Wright FC, Rubin B, Ross H et al. The psychological burden of waiting for procedures and patient-centred strategies that could support the mental health of wait-listed patients and caregivers during the COVID-19 pandemic: A scoping review. Health Expect. 2021.","DOI":"10.1111\/hex.13241"},{"key":"1724_CR2","doi-asserted-by":"crossref","unstructured":"Kwong DLW, Nicholls J, Wei WI, Chua DTT, Ch MBB, Sham JST et al. The Time Course of Histologic Remission after Treatment of Patients with Nasopharyngeal Carcinoma. 1999.","DOI":"10.1002\/(SICI)1097-0142(19990401)85:7<1446::AID-CNCR4>3.0.CO;2-3"},{"issue":"8","key":"1724_CR3","doi-asserted-by":"publisher","first-page":"972","DOI":"10.1002\/bjs.9811","volume":"102","author":"D Pettersson","year":"2015","unstructured":"Pettersson D, L\u00f6rinc E, Holm T, Iversen H, Cedermark B, Glimelius B, et al. Tumour regression in the randomized Stockholm III trial of radiotherapy regimens for rectal cancer. Br J Surg. 2015;102(8):972\u20138.","journal-title":"Br J Surg"},{"key":"1724_CR4","unstructured":"Tan VS, Correa RJM, Nguyen TK, Louie AV, Malthaner RA, Fortin D et al. Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer (MISSILE): Long-Term Clinical Outcomes. Int J Radiat Oncol Biol Phys. 2024 Jan [cited 2024 Dec 11];121(1):39\u201344. Available from: https:\/\/pubmed.ncbi.nlm.nih.gov\/39362312\/"},{"issue":"24","key":"1724_CR5","doi-asserted-by":"publisher","first-page":"3987","DOI":"10.1200\/JCO.2008.16.9896","volume":"26","author":"AP Brown","year":"2008","unstructured":"Brown AP, Wendler DS, Camphausen KA, Miller FG, Citrin D. Performing nondiagnostic research biopsies in irradiated tissue: A review of scientific, clinical, and ethical considerations. J Clin Oncol. 2008;26(24):3987\u201394.","journal-title":"J Clin Oncol"},{"key":"1724_CR6","doi-asserted-by":"crossref","unstructured":"Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8 [cited 2025 Feb 1];350. Available from: https:\/\/www.bmj.com\/content\/350\/bmj.h2147","DOI":"10.1136\/bmj.h2147"},{"key":"1724_CR7","doi-asserted-by":"publisher","unstructured":"Ford I, Norrie J. Pragmatic Trials. New England Journal of Medicine. 2016 Aug 4 [cited 2025 Feb 7];375(5):454\u201363. Available from: https:\/\/www.nejm.org\/doi\/full\/https:\/\/doi.org\/10.1056\/NEJMra1510059","DOI":"10.1056\/NEJMra1510059"},{"key":"1724_CR8","doi-asserted-by":"crossref","unstructured":"Hui D, Bruera E. The Edmonton symptom assessment system 25 years later: past, present, and future developments. Journal of Pain and Symptom Management. Elsevier Inc.; 2017;53:630\u201343.","DOI":"10.1016\/j.jpainsymman.2016.10.370"}],"container-title":["BMC Palliative Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12904-025-01724-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12904-025-01724-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12904-025-01724-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T02:56:25Z","timestamp":1743994585000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcpalliatcare.biomedcentral.com\/articles\/10.1186\/s12904-025-01724-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,7]]},"references-count":8,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["1724"],"URL":"https:\/\/doi.org\/10.1186\/s12904-025-01724-3","relation":{},"ISSN":["1472-684X"],"issn-type":[{"value":"1472-684X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,7]]},"assertion":[{"value":"8 February 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 March 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 April 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study is centrally approved by the Ontario Central Research Ethics Board (OCREB; approval number CTO4663) and by Lawson Research Ethics Board (approval number R-24-092). All participants provided informed consent before taking part in the research, and the study adhered to the ethical guidelines outlined in the Declaration of Helsinki.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All participants will be required to provide explicit consent for their anonymized data and any relevant findings to be published in scientific journals and other scholarly outlets. This consent will be obtained as part of the informed consent process before data collection.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Written, informed consent will be obtained from all participants prior to enrolment. Patients enrolled will be informed of all aspects of the study, including the potential risks and benefits involved. They will be given sufficient time and opportunity to ask questions prior to deciding about participating in the study and be informed that participation in the study is voluntary and that they are completely free to refuse to enter the study or to withdraw from it at any time, for any reason.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"This study does not require a data safety monitoring board.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data safety monitoring board"}},{"value":"The authors declare no competing interests.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"96"}}