Adjuvant X-ray & 5-Fluorouracil (5-FU) Infusion Study
| ISRCTN | ISRCTN32414363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32414363 |
| Secondary identifying numbers | UK01 (AXIS) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 12/04/2012
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=95
Contact information
Dr Dionne Cain
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | AXIS |
| Study objectives | To assess the efficacy and safety of peri-operative radiotherapy for rectal cancer and portal vein infusion of 5-fluorouracil in colon and rectal cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | There are four treatment groups with all groups receiving surgery. 1. The first group receives peri-operative radiotherapy 2. The second group receives portal-vein infusion 3. The third group receives peri-operative radiotherapy plus portal-vein infusion 4. The fourth group receives surgery alone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluorouracil (5-FU) |
| Primary outcome measure | Survival time; Local recurrence; Metastases |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/1989 |
| Completion date | 31/12/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 4000 |
| Key inclusion criteria | 1. Suspected malignant carcinoma of rectum or colon 2. The patient must be fit for external radiation therapy (XRT) or 5-FU if allocated 3. The surgeon is uncertain whether adjuvant treatment is indicated |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/1989 |
| Date of final enrolment | 31/12/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/10/2003 | Yes | No |
