Adjuvant X-ray & 5-Fluorouracil (5-FU) Infusion Study
| ISRCTN | ISRCTN32414363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32414363 |
| Protocol serial number | UK01 (AXIS) |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluorouracil (5-FU) |
| Primary outcome measure(s) |
Survival time; Local recurrence; Metastases |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
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 | 01/10/2003 | Yes | No |
