Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/05/2012
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

COMBAT COIRE

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

No ethics approval information required 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

Colon, Rectal cancer

Intervention

1. Regimen one: continuous infusion 5-fluorouracil. The infusion will be given for 12 weeks and for a further 12 weeks in responding patients or patients with stable disease.
2. Regimen two: continuous infusion 5-fluorouracil given as above plus mitomycin-C given every 6 weeks for two courses and to a total of four courses in responding patients or patients with stable disease.

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil, 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

13/03/1995

Overall trial end date

13/03/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological evidence of metastatic adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy
2. Patients evaluable for response must have bi-dimensionally measurable disease
3. Patients with no measurable disease
4. Adequate bone marrow function
5. Serum creatinine within normal range
6. Life expectancy of greater than 3 months
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200 (final: 98 active, 97 controls)

Participant exclusion criteria

1. History of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix
2. Prior treatment with any cytotoxic agent except adjuvant chemotherapy completed more than 12 months from randomisation
3. Intracerebral metastases or meningeal carcinomatosis
4. Medical contraindications to treatment

Recruitment start date

13/03/1995

Recruitment end date

13/03/1996

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

Hospital/treatment centre

Funder name

The Royal Marsden 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

1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9402173

Publication citations

  1. Results

    Ross P, Norman A, Cunningham D, Webb A, Iveson T, Padhani A, Prendiville J, Watson M, Massey A, Popescu R, Oates J, A prospective randomised trial of protracted venous infusion 5-fluorouracil with or without mitomycin C in advanced colorectal cancer., Ann. Oncol., 1997, 8, 10, 995-1001.

Additional files

Editorial Notes