Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
11/01/2016
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 920

Study information

Scientific title

A pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma

Acronym

Study hypothesis

Not provided at time of registration

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

Colorectal carcinoma

Intervention

1. 5FU (Protracted venous infusion [PVI]) 12 weeks (300 mg/m2)
2. 5FU + Folinic Acid (NCCTG) (425 mg/m2 + 20 mg/m2) every 28 days for six courses

Intervention type

Drug

Phase

Not Applicable

Drug names

5-fluorouracil, leucovorin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/08/1993

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adenocarcinoma - Dukes stage B or C
2. No evidence of residual or metastatic disease assessed at surgery, clinically or radiologically

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

19/08/1993

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
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

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

Publication citations

Additional files

Editorial Notes

11/01/2016: no publications found on PubMed.