A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma
ISRCTN | ISRCTN95638591 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
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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
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Charity
Medical Research Council (UK)
Government organisation / National government
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 | |
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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? |
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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.