A Randomised Trial Comparing the Efficacy of Infusional 5-Fluorouracil (5-FU) to 5-FU plus Alpha Interferon in Patients with Unresectable Colorectal Cancer
| ISRCTN | ISRCTN42493631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42493631 |
| Secondary identifying numbers | COLO 1 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 09/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colon, Rectum |
| Intervention | 1. Regimen A: 5-fluorouracil, continuous intravenous infusion 2. Regimen B: 5-fluorouracil, continuous intravenous infusion, plus alpha-interferon five mega units given subcutaneously three times a week for the duration of 5-fluorouracil treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil Alpha Interferon |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Histological evidence of metastatic adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease 3. Patients with no measurable disease 4. No prior treatment with 5-fluorouracil or other cyctotoxic agent or interferon 5. Adequate bone marrow function 6. Life expectancy of greater than 3 months 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 8. No history of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix 9. No intracerebral metastases or meningeal carcinomatosis 10. No medical contraindications to treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Government
Royal Marsden Hospital NHS Trust (UK)
No information available
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 |
