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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN57511337
Date of registration: 19/08/2002
Prospective Registration: No
Primary sponsor: UK Co-ordinating Committee for Cancer Research (UKCCCR)
Public title: UKCCCR Anal Cancer Trial: Prospective Randomised Trial of Combined Modality Therapy versus Radiation Alone in the Management of Anal Cancer
Scientific title:
Date of first enrolment: 01/01/1990
Target sample size: 585
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN57511337
Study type:  Interventional
Study design:  Randomised controlled trial (Not Specified)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: -    -
Address:  UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road NW1 2DA London United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Anus cancer
Cancer
Anus
Intervention(s)
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.
Primary Outcome(s)
Not provided at time of registration
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
UKCCCRANAL1
Source(s) of Monetary Support
UKCCCR (UK)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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