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 |
| Protocol serial number | CR04 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil, Leucovorin, Interferon-Alpha 2a |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 260 |
| 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
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
