A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma

ISRCTN ISRCTN95638591
DOI https://doi.org/10.1186/ISRCTN95638591
Secondary identifying numbers CR04
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
15/11/2019
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

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
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
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma
Study objectivesNot provided at time of registration.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedAdvanced colorectal adenocarcinoma
InterventionPatients are randomised to one of two treatment arms:

1. Arm 5FU-LV: Chemotherapy with 5-fluorouracil and leucovorin repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease.

2. Arm 5LU-LV-IFN: Chemotherapy with 5-fluorouracil and leucovorin plus interferon-alpha repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)5-Fluorouracil, Leucovorin, Interferon-Alpha 2a
Primary outcome measureNot provided at time of registration.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/08/2000
Completion date01/08/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration.
Total final enrolment260
Key inclusion criteria1. Histologically confirmed adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy
2. Objectively assessable disease
3. No previous treatment with 5-fluorouracil or interferon
4. Adequate bone marrow function
5. No concurrent uncontrolled medical illness
6. Not on systemic corticosteroids at the time of study entry
7. Life expectancy of >3 months
8. World Health Organisation (WHO) performance status 0-2
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/08/2000
Date of final enrolment01/08/2005

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

Charity

Medical Research Council (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 01/08/1996 15/11/2019 Yes No

Editorial Notes

15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.