|
ISRCTN
|
ISRCTN42493631
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Randomised Trial Comparing the Efficacy of Infusional 5-Fluorouracil (5-FU) to 5-FU plus Alpha Interferon in Patients with Unresectable Colorectal Cancer
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
COLO 1
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Colon, Rectum
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2002
|
|
Anticipated end date
|
31/12/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Royal Marsden Hospital NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
The Royal Marsden NHS Foundation Trust (UK)
|
|
Address
|
Downs Road
|
|
City/town
|
Sutton
|
|
Zip/Postcode
|
SM2 5PT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 8661 3156
|
|
Fax
|
+44 (0)20 8643 9414
|
|
Email
|
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
02/10/2006
|
|
Date ISRCTN assigned
|
19/08/2002
|
