Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UK01 (AXIS)
Study information
Scientific title
Acronym
AXIS
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Fluorouracil (5-FU)
Primary outcome measures
Survival time; Local recurrence; Metastases
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1989
Overall trial end date
31/12/1997
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
4000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/1989
Recruitment end date
31/12/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results on http://www.ncbi.nlm.nih.gov/pubmed/14515287
Publication citations
-
Results
James RD, Donaldson D, Gray R, Northover JM, Stenning SP, Taylor I, , Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)., Br J Surg, 2003, 90, 10, 1200-1212, doi: 10.1002/bjs.4266.