{"registry": "ISRCTN", "registryId": "ISRCTN28785842", "source": "https://www.isrctn.com/ISRCTN28785842", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN28785842/format/default", "fetchedAt": "2026-10-07T17:01:20.021767Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Pathology-guided treatment of rectal cancer", "scientificTitle": "Pathology-guided treatment of rectal cancer: a randomised controlled trial", "acronym": "", "hypothesis": "In inoperable rectal cancer: are local recurrence-free survival rates and quality of life optimised by giving all patients short course pre-operative radiotherapy, or is it a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?", "primaryOutcome": "Local recurrence (as defined using an algorithm designed for the trial).", "secondaryOutcome": "1. Local recurrence-free survival\n2. Overall survival\n3. Time to appearance of distant metastases\n4. Disease-free survival\n5. Morbidity\n6. Quality of life \n7. Economic implications", "intervention": "\n\t1. One group receives a short course pre-operative radiotherapy followed by surgery\n2. The other group receives surgery followed by postoperative chemo-radiotherapy\n\tOther\n\tNot Specified\n\t\n      ", "condition": "\n\tRectal cancer\n\tCancer\n\tRectal cancer\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2005-08-05T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00003422", "lastUpdated": "2018-10-17T08:55:34.681Z", "eligibility": {"inclusion": "1. Histologically confirmed adenocarcinoma of the rectum\n2. Considered potentially operable\n3. No evidence of metastases\n4. Patient considered fit to receive either arm of the trial\n5. No concurrent uncontrolled medical illness\n6. No previous or current malignant disease likely to interfere with treatment or comparisons\n7. Informed consent obtained", "exclusion": "Not provided at time of registration", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "1998-02-01T00:00:00.000Z", "recruitmentEnd": "2005-08-05T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "1350", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England", "Canada"], "locations": [{"name": "Leeds Cancer Centre", "city": "Leeds", "state": "", "country": "United Kingdom", "zip": "LS16 6QB"}], "sponsors": [{"organisation": "Medical Research Council (MRC) (UK)", "sponsorType": "Research council"}], "funders": [{"name": "Medical Research Council (MRC) (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000265"}]}, "studySha256": "21fd9f2ac8bdc758f70e8b896b82eefb15c3fcd4deab6b0ea51994b385ca2353"}