A pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma
| ISRCTN | ISRCTN92933910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92933910 |
| Protocol serial number | RMH E/C 920 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 11/01/2016
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colorectal carcinoma |
| Intervention | 1. 5FU (Protracted venous infusion [PVI]) 12 weeks (300 mg/m2) 2. 5FU + Folinic Acid (NCCTG) (425 mg/m2 + 20 mg/m2) every 28 days for six courses |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil, leucovorin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Adenocarcinoma - Dukes stage B or C 2. No evidence of residual or metastatic disease assessed at surgery, clinically or radiologically |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/08/1993 |
| Date of final enrolment | 31/12/2003 |
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/01/2016: no publications found on PubMed.
