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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN53478221
Date of registration:	19/08/2002
Prospective Registration:	No
Primary sponsor:	The Royal Marsden NHS Foundation Trust (UK)
Public title:	A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without mitomycin-C in patients with neuroendocrine tumours
Scientific title:
Date of first enrolment:	12/09/1995
Target sample size:	0
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN53478221
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	David Cunningham
Address:	Department of Medicine Royal Marsden NHS Trust Downs Road SM2 5PT Sutton United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Neuroendocrine tumours
Cancer
Malignant neoplasm of other endocrine glands and related structures

Intervention(s)

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

Primary Outcome(s)

1. Response rate
2. Toxicity
3. Time to disease progression
4. Survival
5. Quality of life

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

RMH E/N 1169

Source(s) of Monetary Support

Royal Marsden Hospital (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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