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
Protocol serial number	SAFFA
Sponsor	The Royal Marsden NHS Foundation Trust (UK)
Funder	Royal Marsden Hospital (UK)

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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Phone	+44 (0) 20 7670 4723

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drugs
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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