Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
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 study start date
12/09/1995
Overall study 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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study participating centre
Department of Medicine
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
The Royal Marsden NHS Foundation Trust (UK)
Sponsor details
Downs Road
Sutton
SM2 5PT
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/07/2002 | Yes | No |