Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
UKCCCRANAL1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Cancer drugs
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/1990
Overall study end date
11/03/1994
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Sponsor details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Sponsor type
Government
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/1996 | Yes | No |