{"registry": "ISRCTN", "registryId": "ISRCTN59368779", "source": "https://www.isrctn.com/ISRCTN59368779", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN59368779/format/default", "fetchedAt": "2026-10-07T17:01:32.361675Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Standardisation of breast radiotherapy (START) trial", "scientificTitle": "Standardisation of breast radiotherapy (START) trial", "acronym": "START", "hypothesis": "To test the effects of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, loco-regional tumour control, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.", "primaryOutcome": "In this study several endpoints are being investigated (tumour recurrence, normal tissue effect, quality of life). It is intended that each will be analysed separately. If there is discordance between the endpoints in terms of treatment outcome this will allow discussion of clinical trade-offs. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined.", "secondaryOutcome": "Not provided at time of registration", "intervention": "\n\tRadiotherapy schedules using fraction sizes larger than 2.0 Gy\n\tOther\n\tNot Specified\n\t\n      ", "condition": "\n\tBreast cancer\n\tCancer\n\tBreast cancer\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2002-10-24T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00005588", "lastUpdated": "2022-10-25T15:27:18.010501Z", "eligibility": {"inclusion": "1. Patients must be 18 years and above, have operable unilateral breast cancer (T1-3, NO-1, MO at presentation) \n2. There must be histological confirmation of invasive carcinoma and complete macroscopic excision of tumour by breast conserving surgery or mastectomy \n3. The patient must consent to be part of the study and be available for follow-up", "exclusion": "Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed", "ageRange": "Adult", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "1999-01-01T00:00:00.000Z", "recruitmentEnd": "2002-10-24T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "4451", "totalFinalEnrolment": "4451"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Department of Radiotherapy", "city": "Sutton", "state": "", "country": "United Kingdom", "zip": "SM2 5PT"}], "sponsors": [{"organisation": "Institute of Cancer Research (UK)", "sponsorType": "Research organisation", "rorId": "https://ror.org/043jzw605"}], "funders": [{"name": "Department of Health"}, {"name": "Medical Research Council (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000265"}, {"name": "Cancer Research UK", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "292489139bddd4edfab2ebe2f19278d9f720e5d3c5d65696077ee6e122b48ead"}