Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UKCCCRANAL1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Anus cancer
Intervention
1. Radiotherapy Alone: Radiotherapy, 45 Gy given in twenty-five fractions over 5 weeks or twenty fractions over 4 weeks.
2. Combined Modality Therapy: Radiotherapy as above plus chemotherapy (mitomycin-C and 5-fluorouracil). Chemotherapy to start on the same initial day as radiotherapy.
Intervention type
Drug
Phase
Not Specified
Drug names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
11/03/1994
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histological proof of epidermoid carcinoma. This includes lesions referred to as squamous cell, basaloid and cloacogenic carcinoma. Adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma and lymphoma are excluded
2. No previous treatment for anal cancer
3. No previous radiotherapy to the pelvis
4. No history of other malignancy, except adequately treated squamous or basal cell carcinoma of the skin or in situ cervical carcinoma
5. No contraindications to either treatment
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added May 2008: 585
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
11/03/1994
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
UKCCCR (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8874455
Publication citations
-
Results
Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research., Lancet, 1996, 348, 9034, 1049-1054.