Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
18/01/2016
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

COLORAD

Study information

Scientific title

A randomised trial of infusional 5-fluorouracil and concomitant radiotherapy in locally advanced rectal cancer, comparing three and six months of infusional 5-fluorouracil

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

Cancer of rectum

Intervention

All patients receive continuous infusional 5-fluorouracil for 12 weeks plus radiotherapy to the pelvis, minimum 45 Gy given in twenty-five fractions over 5 weeks to start at the beginning of the 5th week of chemotherapy.

Depending upon the initial randomisation, patients receive either:
1. Group One: Continuous infusional 5-fluorouracil for a further 12 weeks.
2. Group Two: No further chemotherapy with 5-fluorouracil.

Intervention type

Drug

Phase

Not Applicable

Drug names

5-fluorouracil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

11/11/1994

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically verified adenocarcinoma of the rectum, which is either:
1.1. Inoperable primary tumour
1.2. Locally recurrent tumour
1.3. Residual pelvic disease after resection as assessed either surgically or histopathologically
2. No evidence of metastatic disease
3. No past history of malignancy
4. No previous radiotherapy to the pelvis
5. Normal bone marrow, liver and renal function
6. No concurrent severe or life threatening illness

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

01/01/1990

Recruitment end date

11/11/1994

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

18/01/2016: no publications found on PubMed.