A randomised study of continuous infusional 5-fluorouracil with or without bolus mitomycin-C in patients with advanced colorectal cancer

ISRCTN	ISRCTN27478455
DOI	https://doi.org/10.1186/ISRCTN27478455
Secondary identifying numbers	COMBAT COIRE

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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)	No ethics approval information required at time of registration.
Health condition(s) or problem(s) studied	Colon, Rectal cancer
Intervention	1. Regimen one: continuous infusion 5-fluorouracil. The infusion will be given for 12 weeks and for a further 12 weeks in responding patients or patients with stable disease. 2. Regimen two: continuous infusion 5-fluorouracil given as above plus mitomycin-C given every 6 weeks for two courses and to a total of four courses in responding patients or patients with stable disease.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-fluorouracil, mitomycin-C
Primary outcome measure	Added 05/08/09: 1. tumour response 2. survival 3. toxicity 4. quality of life (QoL)
Secondary outcome measures	Not provided at time of registration
Overall study start date	13/03/1995
Completion date	13/03/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	200 (final: 98 active, 97 controls)
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. Adequate bone marrow function 5. Serum creatinine within normal range 6. Life expectancy of greater than 3 months 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria	1. History of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix 2. Prior treatment with any cytotoxic agent except adjuvant chemotherapy completed more than 12 months from randomisation 3. Intracerebral metastases or meningeal carcinomatosis 4. Medical contraindications to treatment
Date of first enrolment	13/03/1995
Date of final enrolment	13/03/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

"ROR"	https://ror.org/0008wzh48

Hospital/treatment centre

The Royal Marsden NHS Foundation Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/1997		Yes	No