UKCCCR Anal Cancer Trial: Prospective Randomised Trial of Combined Modality Therapy versus Radiation Alone in the Management of Anal Cancer
| ISRCTN | ISRCTN57511337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57511337 |
| Protocol serial number | UKCCCRANAL1 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | UKCCCR (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Cancer drugs |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 11/03/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 585 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 11/03/1994 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/1996 | Yes | No |
