Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/N 1169
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
5-Fluorouracil (5FU), mitomycin-C
Primary outcome measure
1. Response rate
2. Toxicity
3. Time to disease progression
4. Survival
5. Quality of life
Secondary outcome measures
No secondary outcome measures
Overall trial start date
12/09/1995
Overall trial end date
26/11/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
12/09/1995
Recruitment end date
26/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Sutton
SM2 5PT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12118027
Publication citations
-
Results
Maisey N, Chau I, Cunningham D, Norman A, Seymour M, Hickish T, Iveson T, O'Brien M, Tebbutt N, Harrington A, Hill M, Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer., J. Clin. Oncol., 2002, 20, 14, 3130-3136.