Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
27/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Cunningham

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12118027

Publication citations

  1. 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.

Additional files

Editorial Notes