{"registry": "ISRCTN", "registryId": "ISRCTN26715889", "source": "https://www.isrctn.com/ISRCTN26715889", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN26715889/format/default", "fetchedAt": "2026-10-07T17:00:17.844588Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A second UK Phase III anal cancer trial: a trial of chemoradiation and maintenance therapy for patients with anal cancer", "scientificTitle": "A second UK Phase III anal cancer trial: a trial of chemoradiation and maintenance therapy for patients with anal cancer", "acronym": "ACT II", "hypothesis": "Following completion of ACT I the standard treatment for anal cancer is a combined modality treatment of radiotherapy, 5-Fluorouracil (5-FU) and mitomycin. However, the schedule used in ACT I may not be optimal and an improvement in outcome may be achieved by intensifying. \n\nUnited Kingdom, European Organisation for Research and Treatment of Cancer (EORTC) and Intergroup pilot studies used three main approaches:\n1. Modification of radiotherapy schedule\n2. Changing the chemotherapy regimen \n3. Additional courses of chemotherapy. \n\nAs a result, to avoid using split course radiotherapy a continuous course of radiotherapy (piloted in over 80 patients) will be used in this trial, cisplatin will be compared to mitomycin and patients will be randomised to maintenance chemotherapy. \n\nCisplatin was chosen as in combination with 5-FU it is active in advanced disease, it produces high Complete Remission (CR) rates in combination with radiotherapy and has activity in other squamous cell carcinomas. \n\nAdditional chemotherapy will be given after treatment as neo-adjuvant chemotherapy has not been shown to improve survival when given in combination with radiotherapy in other tumour sites. In addition the toxicity associated with it may impact on the timing of treatment and on the total dose of chemoradiation delivered.\n\nTherefore, the objectives of this trial are as follows:\n1. Whether Cisplatin or Mitomycin produces a higher CR rate post treatment \n2. Whether Cisplatin or Mitomycin produces a higher grade four acute toxicity\n3. Whether maintenance chemotherapy will improve recurrence-free survival", "primaryOutcome": "1. CR rate (at six months):\n1.1. 90% to detect an increase from 80% to 90%\n1.2. 95% to detect an increase from 85% to 95% \n2. Grade four toxicity: 95% to detect a doubling of the 11% Grade four acute toxicity reported in ACT I\n3. Recurrence-free survival:\n3.1. 80% to detect 11% difference (64% to 75%)\n3.2. 99% to detect 16% difference (64% to 80%)", "secondaryOutcome": "Not provided at time of registration", "intervention": "\n\tFour treatment arms: \n1. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Mitomycin 12 mg/m^2, day one only, intravenous (iv) bolus and no maintenance therapy \n2. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Mitomycin 12 mg/m^2, day one only, iv bolus and maintenance therapy (CDDP)\n3. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Cisplatin 60 mg/m^2, days one and 29 by iv infusion and no maintenance therapy\n4. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Cisplatin 60 mg/m^2, days one and 29 by iv infusion and maintenance therapy (CDDP)\n\nMaintenance therapy consists of:\nTwo courses 5-FU and Cisplatin, four weeks after the end of primary chemoradiation repeated after three weeks:\n5-Fluorouracil 1000 mg/m^2, days one to four and Cisplatin 60 mg/m^2, day one by iv infusion\n\tDrug\n\tPhase II\n\t5-Fluorouracil, Mitomycin and Cisplatin\n      ", "condition": "\n\tAnal cancer\n\tCancer\n\tMalignant neoplasm of anus and anal canal\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2007-08-31T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00025090", "lastUpdated": "2018-10-17T08:51:13.490Z", "eligibility": {"inclusion": "1. Histological proof of epidermoid anal carcinoma (includes squamous, basaloid and cloacogenic lesions)\n2. Patients fit to receive platinum or mitomycin C based chemotherapy determined by: \n2.1. Adequate baseline renal function\n2.2. Acceptable haematological parameters\n2.3. Liver Function Tests (LFTs) within 2 x normal range\n2.4. Adequate cardiac function\n2.5. No serious uncontrolled medical conditions (particularly cardiovascular disease)\n2.6. Written informed consent", "exclusion": "1. Anal cancer that has spread to another part of the body \n2. Adenocarcinoma or muco-epidermoid anal cancer \n3. Lymphoma or melanoma of the anal canal \n4. Pre-cancerous cell changes (intraepithelial neoplasia) that have not developed into anal cancer \n5. Had your cancer completely removed with an operation \n6. Already had treatment for your anal cancer \n7. Had radiotherapy to your pelvic area before \n8. Had any other cancer in the past \n9. Any other serious medical condition", "ageRange": "Not Specified", "gender": "", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2001-02-01T00:00:00.000Z", "recruitmentEnd": "2007-08-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "600", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England"], "locations": [{"name": "MRC Clinical Trials Unit", "city": "London", "state": "", "country": "United Kingdom", "zip": "NW1 2DA"}], "sponsors": [{"organisation": "Cancer Research UK (CRUK) (UK)", "sponsorType": "Charity", "rorId": "https://ror.org/054225q67"}], "funders": [{"name": "Cancer Research UK (CRUK) (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "5ca34835d0d603fb730429b1d7966233a2ebd52d7f0db56945349f8269b878ac"}