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
Protocol serial number	COLO 1
Sponsor	The Royal Marsden NHS Foundation Trust (UK)
Funder	Royal Marsden Hospital NHS Trust (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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-Fluorouracil Alpha Interferon
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002

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

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