A second UK Phase III anal cancer trial: a trial of chemoradiation and maintenance therapy for patients with anal cancer

Phase 2

Completed

• Conditions: Anal cancer; Malignant neoplasm of anus and anal canal; Cancer

• Registration Number: ISRCTN26715889
• Lead Sponsor: Cancer Research UK (CRUK) (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24827136 2017 post-hoc analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/28209296

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-05-31
• Study Completion: 2007-08-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified