{"registry": "ISRCTN", "registryId": "ISRCTN59757862", "source": "https://www.isrctn.com/ISRCTN59757862", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN59757862/format/default", "fetchedAt": "2026-10-07T17:01:29.677116Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer", "scientificTitle": "SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups", "acronym": "SCOT - Short Course Oncology Therapy", "hypothesis": "The study aims to ascertain whether 3 months of treatment is as efficacious as 6 months with the further aim of providing robust evidence on the cost-effectiveness of reducing the duration of adjuvant therapy.", "primaryOutcome": "Non-inferiority question:\nDisease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause).\n\nTiming of randomisation question:\nProjected probability of study completing recruitment with at most a 4-month overrun.", "secondaryOutcome": "Non-inferiority question:\n1. Overall survival\n2. Cost effectiveness\n3. Toxicity\n4. Quality of life\n\nTiming of randomisation question:\nCompliance rate with allocated treatment duration.\n\nFor the purposes of this study patients will be followed up with clinical examination and CEA at 3-monthly intervals until month 12 (end of year 1) then 6-monthly until month 24 (end of year 2). Computed Tomography (CT) scanning will be performed at six-monthly intervals for 2 years and colonoscopy per individual centre protocol. In years 3 to 5 patients will be reviewed at yearly intervals. Investigations will be performed at other times as clinically indicated. \n\nEuropean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire and EORTC QLQ-CR29 (a colorectal module) will be administered prior to randomisation and prior to each treatment cycle. In addition quality of life will be assessed monthly in the experimental arm (3-month arm) for the three months post treatment; there will be follow-up quality of life assessments in both arms at 9 and 12 months of study. \n\nNeurotoxicity will be assessed at the same time points as quality of life using the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity (FACT/GOG Ntx) questionnaire.\n\nIn addition to the disease specific EORTC QOL questionnaires, the generic EuroQoL (EQ-5D) questionnaire will be employed to facilitate the calculation of quality of life utilities suitable for the economic analysis. This will be administered at the same frequency as the EORTC QOL questionnaires.", "intervention": "\n\tControl arm - 6 months of XELOX/FOLFOX chemotherapy\nExperimental arm - 3 months of XELOX/FOLFOX chemotherapy\n\nThe treatment regimen will be either:\n1. Oxaliplatin/capecitabine (XELOX), which is a 3 weekly cycle OR;\n2. Oxaliplatin/5-fluorouracil (5 FU) (FOLFOX), which is a 2 weekly cycle\n\nDepending on which arm the patient draws and which regimen they are given will establish the number of cycles, for example on the control arm receiving XELOX regimen patient would receive 8 cycles at 3 weekly intervals or if receiving FOLFOX regimen on control arm would receive 12 cycles at 2 weekly intervals.\n \nThe same would apply for the experimental arm, for example a patient receiving XELOX regimen would receive 4 cycles at 3 weekly intervals or if receiving FOLFOX regimen 6 cycles at 2 weekly intervals.\n\nXELOX regimen dosage details: three weeks (21 day cycle) oxaliplatin 130 mg/m^2 intravenous (IV) over 2 hours on day one, capecitabine 1000 mg/m^2 on day 1 to day 14, twice daily (bid) (oral).\n\nFOLFOX regimen dosage details: 2 weeks (14-day cycle) oxaliplatin 85 mg/m^2 IV over 2 hours on day 1, 5 FU 400 mg/m^2 on day 1 bolus injection, 5 FU 600 mg/m^2 on day 2 IV over 22 hours, 5 FU 400 mg/m^2 on day 3 bolus injection, 5 FU 600 mg/m^2 day 3 IV over 22 hours.\n \nClinical follow-up once treatment is complete will be monthly for 3 months (experimental arm only), 3 monthly until month 12 (end of year 1), 6-monthly until month 24 (end of year 2), then annually thereafter. The maximum duration of follow-up will be 7 years.\n\tDrug\n\tNot Applicable\n\tOxaliplatin/capecitabine (XELOX), Oxaliplatin/5-fluorouracil (5 FU) (FOLFOX)\n      ", "condition": "\n\tColorectal cancer\n\tCancer\n\tMalignant neoplasm of colon\n      ", "studyDesign": "Open randomized controlled multi-centre non-inferiority trial incorporating a nested methodology study and an initial pilot period", "overallEndDate": "2017-11-30T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00749450", "lastUpdated": "2026-01-12T14:55:26.315008Z", "eligibility": {"inclusion": "Current inclusion criteria as of 10/07/2014:\n1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)\n2. No evidence of metastatic disease\n3. Within 11 weeks of surgery\n4. World Health Organisation Performance Status (WHO PS) equals zero or one\n5. Greater than or equal to 18 years of age\n6. Life expectancy greater than 5 years\n7. Written informed consent\n8. Normal Carcinoembryonic Antigen (CEA)\n9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins\n\nPrevious inclusion criteria:\n1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)\n2. No evidence of metastatic disease\n3. Within eight weeks of surgery\n4. World Health Organisation Performance Status (WHO PS) equals zero or one\n5. Greater than or equal to 18 years of age\n6. Life expectancy greater than five years\n7. Written informed consent\n8. Normal Carcinoembryonic Antigen (CEA)\n9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins", "exclusion": "1. Previous chemotherapy\n2. Previous abdomino-pelvic radiotherapy\n3. Moderate/severe renal impairment (Glomerular Filtration Rate [GFR] less than 30 ml/min)\n4. Absolute neutrophil count less than 1.5 x 10^9\n5. Platelet count less than 100 x 10^9\n6. Haemoglobin less than 9 g/dl\n7. Liver function tests greater than 2.5 Upper Limit of Normal (ULN)\n8. Clinically significant cardiovascular disease\n9. Pregnancy/lactation or of childbearing potential not using adequate contraception\n10. Previous malignancy\n11. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency\n\nIn addition, for the 3-month randomisation point, only patients deemed to be fit to continue treatment will be randomised.", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2008-05-09T00:00:00.000Z", "recruitmentEnd": "2013-11-29T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "6144", "totalFinalEnrolment": "6088"}, "countries": ["United Kingdom", "Scotland"], "locations": [{"name": "Beatson West of Scotland Cancer Centre", "city": "Glasgow", "state": "", "country": "Scotland", "zip": "G12 0YN"}], "sponsors": [{"organisation": "NHS Greater Glasgow and Clyde", "sponsorType": "Government", "rorId": "https://ror.org/05kdz4d87"}, {"organisation": "University of Glasgow", "sponsorType": "University/education", "rorId": "https://ror.org/00vtgdb53"}], "funders": [{"name": "Medical Research Council (MRC) (UK) (ref: G0601705)", "fundRef": "http://dx.doi.org/10.13039/501100000265"}]}, "studySha256": "39260ec595d9e6fdafefab5225fd2c3549f57370029375460446f47bf5823e6c"}