A randomised trial of intravenous versus intrahepatic arterial 5-Flurouracil (5-FU) and leucovorin for colorectal liver metastases

ISRCTN	ISRCTN78734883
DOI	https://doi.org/10.1186/ISRCTN78734883
ClinicalTrials.gov (NCT)	NCT00002692
Protocol serial number	CR05
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Dionne Cain
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare the efficacy and safety of intravenous and intrahepatic arterial infusion of 5-FU and leucovorin.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	Intrahepatic arterial infusion of 5-FU/leucovorin
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	fluorouracil, leucovorin calcium
Primary outcome measure(s)	Survival time
Key secondary outcome measure(s)	Quality of life, objective tumour response, duration of response, toxicity.
Completion date	31/08/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	290
Key inclusion criteria	1. Histologically confirmed adenocarcinoma of the colon or rectum, confined to the liver, and not amenable to surgery or found to be unresectable during surgery 2. No previous treatment with 5-FU with the exception of adjuvant therapy (eg AXIS or QUASAR studies) completed more than 12 months prior to study entry 3. Adequate bone marrow function with platelets more than 100 x 10 to the power of 9 per litre; White Blood Count (WBC) more than 3.0 x 10 to the power of 9 per litre and neutrophils more than 1.5 x 10 to the power of 9 per litre at the time of study entry 4. No concurrent uncontrolled medical illness (eg uncontrolled heart failure, angina, infection, etc) 5. Life expectancy more than 3 months 6. WHO performance status 0, 1 or 2 7. Bilirubin less than 50 micromoles per litre
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/12/1994
Date of final enrolment	31/08/2000

MRC Clinical Trials Unit

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?
Results article	results	01/02/2003		Yes	No