A Pilot Randomised Trial Comparing Short Course Infusional 5-Fluourouracil with 5-Fluorouracil and Leucovorin as Adjuvant Therapy for Resected Colorectal Carcinoma
| ISRCTN | ISRCTN21284267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21284267 |
| Secondary identifying numbers | SAFFA |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/11/2012
- 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
| Phone | +44 (0) 20 7670 4723 |
|---|
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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: Continuous infusion of 5-fluorouracil over 12 weeks. 2. Regimen B: Folinic acid intravenous bolus injection, followed by 5-fluorouracil intravenous bolus injection given on 5 consecutive days and repeated every 28 days for six cycles |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cancer drugs |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/08/1993 |
| Completion date | 31/12/2006 |
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. Histologically verified adenocarcinoma of colon or rectum, Dukes stages B or C 2. No evidence of residual local disease or metastatic disease as assessed at time of operation, clinical examination, and by ultrasound scanning 3. No past history of malignancy apart from non melanotic carcinoma of the skin or in-situ carcinoma of the cervix 4. No previous chemotherapy 5. Normal bone marrow, renal and liver function 6. Patients must be randomised within 10 weeks of surgery 7. No medical contraindications to treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/08/1993 |
| Date of final enrolment | 31/12/2006 |
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
Research organisation
Royal Marsden Hospital (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 |
