Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CR04
Study information
Scientific title
A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma
Acronym
Study hypothesis
Not provided at time of registration.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/08/2000
Overall trial end date
01/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration.
Total final enrolment
260
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/08/2000
Recruitment end date
01/08/2005
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
Charity
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
1996 results in: https://www.ncbi.nlm.nih.gov/pubmed/8708718 (added 15/11/2019)