Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/06/2012
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

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RMH E/C 1041

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date.

Ethics approval

Not provided at time of registration

Study design

Multicentre 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

Pancreatic cancer

Intervention

Two Arms:
1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks
2. PVI 5FU 300 mg/m2/day over 24 weeks MMC 7 mg/m2 (total dose not to exceed 56 mg) four courses over 24 weeks

Intervention type

Drug

Phase

Not Specified

Drug names

5-Fluorouracil (5FU), mitomycin-C

Primary outcome measures

Added 05/08/09:
1. tumour response
2. survival
3. toxicity
4. quality of life (QoL)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Histological evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy. Alternatively patients would have radiologically measurable evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy, without histological evidence but with a carcinoembryonic antigen (CEA) above 50.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Final recruitment: 208 (added 05/08/09)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/1995

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
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

Research organisation

Funder name

Royal Marsden Hospital NHS Foundation Trust (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