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| [ Print-friendly version ] |
| A Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients with Anal Cancer |
| ISRCTN | ISRCTN26715889 |
| ClinicalTrials.gov identifier | NCT00025090 |
| 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 |
| Serial number at source | ACT II |
| 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 |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Anal cancer |
| 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 |
| Anticipated start date | 01/02/2001 |
| Anticipated end date | 31/08/2007 |
| Status of trial | Completed |
| Patient information material | |
| 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 provided at time of registration |
| Sources of funding | Cancer Research UK |
| Trial website | |
| Publications | |
| Contact name | Dr - - |
| Address |
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit 222 Euston Road |
| City/town | London |
| Zip/Postcode | NW1 2DA |
| Country | United Kingdom |
| Tel | +44 (0) 20 7670 4723 |
| Fax | +44 (0) 20 7670 4818 |
| register@ctu.mrc.ac.uk | |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Address |
PO Box 123
Lincoln's Inn Fields |
| City/town | London |
| Zip/Postcode | WC2A 3PX |
| Country | United Kingdom |
| Tel | +44 (0)20 7317 5186 |
| Fax | +44 (0)20 7487 4302 |
| kate.law@cancer.org.uk | |
| Sponsor website: | http://www.cancer.org.uk |
| Date applied | 31/05/2001 |
| Last edited | 04/10/2007 |
| Date ISRCTN assigned | 31/05/2001 |
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