Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
COMBAT COIRE
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
5-fluorouracil, mitomycin-C
Primary outcome measure
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 study start date
13/03/1995
Overall study end date
13/03/1996
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/1997 | Yes | No |