A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without mitomycin-C in patients with neuroendocrine tumours

ISRCTN	ISRCTN53478221
DOI	https://doi.org/10.1186/ISRCTN53478221
Protocol serial number	RMH E/N 1169
Sponsor	The Royal Marsden NHS Foundation Trust (UK)
Funder	Royal Marsden Hospital (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Cunningham
Scientific

Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	To compare the response rate and quality of life in patients having these regimens.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neuroendocrine tumours
Intervention	Two arms: Regimen 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks Regimen 2. PVI 5FU 300 mg/m2/day over 24 weeks Mitomycin-C 7 mg/m2 (total dose must not exceed 56 mg) four courses over 24 weeks
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-Fluorouracil (5FU), mitomycin-C
Primary outcome measure(s)	1. Response rate 2. Toxicity 3. Time to disease progression 4. Survival 5. Quality of life
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	26/11/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	1. Histological evidence of neuroendocrine tumours not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease as assessed by chest X-ray or computed tomography (CT) scan 3. This disease must be outside previously irradiated areas
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	12/09/1995
Date of final enrolment	26/11/2003

Department of Medicine

Sutton
SM2 5PT
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	15/07/2002		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes