|
ISRCTN
|
ISRCTN53478221
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without mitomycin-C in patients with neuroendocrine tumours
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RMH E/N 1169
|
|
Study hypothesis
|
To compare the response rate and quality of life in patients having these regimens.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Neuroendocrine tumours
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
12/09/1995
|
|
Anticipated end date
|
26/11/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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 measure(s)
|
1. Response rate
2. Toxicity
3. Time to disease progression
4. Survival
5. Quality of life
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
Royal Marsden Hospital (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
David
Cunningham
|
|
Address
|
Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
|
|
City/town
|
Surrey
|
|
Zip/Postcode
|
SM2 5PT
|
|
Country
|
United Kingdom
|
|
Sponsor
|
The Royal Marsden NHS Foundation Trust (UK)
|
|
Address
|
Downs Road
|
|
City/town
|
Sutton
|
|
Zip/Postcode
|
SM2 5PT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 8661 3156
|
|
Fax
|
+44 (0)20 8643 9414
|
|
Email
|
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
19/05/2008
|
|
Date ISRCTN assigned
|
19/08/2002
|
