{"registry": "ISRCTN", "registryId": "ISRCTN95889329", "source": "https://www.isrctn.com/ISRCTN95889329", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN95889329/format/default", "fetchedAt": "2026-10-07T17:01:25.713337Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Post-operative Radiotherapy In Minimum-risk Elderly - Phase II", "scientificTitle": "Post-operative Radiotherapy In Minimum-risk Elderly - Phase II", "acronym": "PRIME II", "hypothesis": "To assess the role of post-operative breast radiotherapy in women aged 65 or older, with low risk breast cancer treated by breast conserving surgery and adjuvant endocrine therapy: in particular to estimate the difference in local recurrence rates between patients treated with and without radiotherapy.\n\nThis trial is related to PRIME I  and details in http://www.controlled-trials.com/ISRCTN14817328", "primaryOutcome": "Ipsilateral breast cancer recurrence rates", "secondaryOutcome": "Regional recurrence, contralateral breast cancer, distant metastases, disease free survival and overall survival", "intervention": "\n\tThe control arm receive standard breast irradiation (40-50 Gy) over 3-6 weeks and the experimental group receive no breast irradiation. All eligible patients are to receive some form of endocrine therapy.\n\tOther\n\tNot Specified\n\t\n      ", "condition": "\n\tBreast cancer\n\tCancer\n\tBreast\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2008-11-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2023-02-16T13:38:54.414372Z", "eligibility": {"inclusion": "1. Breast conserving surgery with a complete pathological excision margin of all invasive and non invasive cancer (a minimum of 1 mm on histological assessment)\n2. Histologically confirmed unilateral breast cancer of pathological size 3 cm or less\n3. Oestrogen receptor or progesterone receptor positive and treated with post-operative adjuvant endocrine therapy (patients who have been treated with pre-operative neo-adjuvant endocrine therapy can be included)\n4. No axillary node involvement on histological assessment\n5. Medically suitable to attend for all treatment and follow up\n6. Able and willing to give informed consent", "exclusion": "1. Age younger than 65 years (date of issue of pathology results)\n2. Grade III cancer combined with lymphatic/vascular invasion\n3. Previous in situ or invasive carcinoma of either breast\n4. Current or previous malignancy, within the past 5 years, other than non-melanomatous skin cancer or carcinoma in situ of cervix", "ageRange": "Senior", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2003-01-01T00:00:00.000Z", "recruitmentEnd": "2008-11-30T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "1000", "totalFinalEnrolment": "1326"}, "countries": ["United Kingdom", "Scotland"], "locations": [{"name": "Edinburgh Cancer Centre", "city": "Edinburgh", "state": "", "country": "United Kingdom", "zip": "EH4 2XU"}], "sponsors": [{"organisation": "University of Edinburgh (UK)", "sponsorType": "University/education", "rorId": "https://ror.org/01nrxwf90"}], "funders": [{"name": "Robertson Trust, Glasgow. Trial was allowed to use unspent funds from another trial to set up the initial stages of the trial."}, {"name": "Chief Scientist Office, Scottish Executive (ref CZH/4/296)"}]}, "studySha256": "bace0f4bebf2af23ddcdb3a58a0fb503a68aaf976a95dea549926b3b23287771"}