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
Secondary identifying numbers RMH E/N 1169
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
27/06/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Cunningham
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo 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) studiedNeuroendocrine tumours
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)5-Fluorouracil (5FU), mitomycin-C
Primary outcome measure1. Response rate
2. Toxicity
3. Time to disease progression
4. Survival
5. Quality of life
Secondary outcome measuresNo secondary outcome measures
Overall study start date12/09/1995
Completion date26/11/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment12/09/1995
Date of final enrolment26/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Medicine
Sutton
SM2 5PT
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Hospital/treatment centre

Royal Marsden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/07/2002 Yes No