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ISRCTN
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ISRCTN57511337
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ClinicalTrials.gov identifier
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Public title
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UKCCCR Anal Cancer Trial: Prospective Randomised Trial of Combined Modality Therapy versus Radiation Alone in the Management of Anal Cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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UKCCCRANAL1
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Anus cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1990
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Anticipated end date
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11/03/1994
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added May 2008: 585
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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UKCCCR (UK)
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Trial website
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Publications
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1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8874455
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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Date applied
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19/08/2002
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Last edited
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27/05/2008
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Date ISRCTN assigned
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19/08/2002
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