Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Dionne Cain

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes