Anal cancer Cancer Malignant neoplasm of anus and anal canal
Conditions
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 thera
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Inclusion criteria
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: 2.1. Adequate baseline renal function 2.2. Acceptable haematological parameters 2.3. Liver Function Tests (LFTs) within 2 x normal range 2.4. Adequate cardiac function 2.5. No serious uncontrolled medical conditions (particularly cardiovascular disease) 2.6. Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CR rate (at six months): 1.1. 90% to detect an increase from 80% to 90% 1.2. 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: 3.1. 80% to detect 11% difference (64% to 75%) 3.2. 99% to detect 16% difference (64% to 80%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed