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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Advanced colorectal adenocarcinoma
Intervention	Patients 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 type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	5-Fluorouracil, Leucovorin, Interferon-Alpha 2a
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/08/2000
Completion date	01/08/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration.
Total final enrolment	260
Key inclusion criteria	1. 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 criteria	Not provided at time of registration.
Date of first enrolment	01/08/2000
Date of final enrolment	01/08/2005

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	01/08/1996	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.