Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
COLO 1
Study information
Scientific title
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Colon, Rectum
Intervention
1. Regimen A: 5-fluorouracil, continuous intravenous infusion
2. Regimen B: 5-fluorouracil, continuous intravenous infusion, plus alpha-interferon five mega units given subcutaneously three times a week for the duration of 5-fluorouracil treatment
Intervention type
Drug
Phase
Not Specified
Drug names
5-Fluorouracil
Alpha Interferon
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
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. No prior treatment with 5-fluorouracil or other cyctotoxic agent or interferon
5. Adequate bone marrow function
6. Life expectancy of greater than 3 months
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
8. No history of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix
9. No intracerebral metastases or meningeal carcinomatosis
10. No medical contraindications to treatment
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
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Government
Funder name
Royal Marsden Hospital NHS 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