|
Welcome
|
|
11 October 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| A Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients with Anal Cancer |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN26715889 |
| Date ISRCTN assigned | 31/05/2001 |
| Local reference number(s) | ACT II |
| Public title | A Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients with Anal Cancer |
| Scientific title | |
| Acronym | ACT II |
| Disease/condition/study domain | Anal cancer |
| Study 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. United Kingdom, European Organisation for Research and Treatment of Cancer (EORTC) and Intergroup pilot studies used three main approaches: 1. Modification of radiotherapy schedule 2. Changing the chemotherapy regimen 3. Additional courses of chemotherapy. As 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. Cisplatin 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. Additional 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. Therefore, the objectives of this trial are as follows: 1. Whether Cisplatin or Mitomycin produces a higher CR rate post treatment 2. Whether Cisplatin or Mitomycin produces a higher grade four acute toxicity 3. Whether maintenance chemotherapy will improve recurrence-free survival |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological proof of epidermoid anal carcinoma (includes squamous, basaloid and cloacogenic lesions) 2. Patients fit to receive platinum or mitomycin C based chemotherapy determined by: a. Adequate baseline renal function b. Acceptable haematological parameters c. Liver Function Tests (LFTs) within 2 x normal range d. Adequate cardiac function e. No serious uncontrolled medical conditions (particularly cardiovascular disease) f. Written informed consent |
| Participants - exclusion criteria | 1. Anal cancer that has spread to another part of the body 2. Adenocarcinoma or muco-epidermoid anal cancer 3. Lymphoma or melanoma of the anal canal 4. Pre-cancerous cell changes (intraepithelial neoplasia) that have not developed into anal cancer 5. Had your cancer completely removed with an operation 6. Already had treatment for your anal cancer 7. Had radiotherapy to your pelvic area before 8. Had any other cancer in the past 9. Any other serious medical condition |
| Patient information material | |
| Anticipated start date | 01/02/2001 |
| Anticipated end date | 31/08/2007 |
| Status of trial | Completed |
| Target number of participants | 600 |
| Interventions | Four treatment arms: 1. 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 2. 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) 3. 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 4. 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) Maintenance therapy consists of: Two courses 5-FU and Cisplatin, four weeks after the end of primary chemoradiation repeated after three weeks: 5-Fluorouracil 1000 mg/m^2, days one to four and Cisplatin 60 mg/m^2, day one by iv infusion |
| Primary outcome measure(s) | 1. CR rate (at six months): a. 90% to detect an increase from 80% to 90% b. 95% to detect an increase from 85% to 95% 2. Grade four toxicity: 95% to detect a doubling of the 11% Grade four acute toxicity reported in ACT I 3. Recurrence-free survival: a. 80% to detect 11% difference (64% to 75%) b. 99% to detect 16% difference (64% to 80%) |
| Secondary outcome measure(s) | Not applicable |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123 Lincoln's Inn Fields London United Kingdom WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN26715889 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
| terms & conditions | privacy statement | © Current Controlled Trials Ltd | |
|
|
|
|