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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymAXIS
Study objectivesTo 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) studiedCancer
InterventionThere 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fluorouracil (5-FU)
Primary outcome measureSurvival time; Local recurrence; Metastases
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1989
Completion date31/12/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants4000
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/11/1989
Date of final enrolment31/12/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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