Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
SAFFA
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colon, Rectum
Intervention
1. Regimen A: Continuous infusion of 5-fluorouracil over 12 weeks.
2. Regimen B: Folinic acid intravenous bolus injection, followed by 5-fluorouracil intravenous bolus injection given on 5 consecutive days and repeated every 28 days for six cycles
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Cancer drugs
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
19/08/1993
Overall study end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically verified adenocarcinoma of colon or rectum, Dukes stages B or C
2. No evidence of residual local disease or metastatic disease as assessed at time of operation, clinical examination, and by ultrasound scanning
3. No past history of malignancy apart from non melanotic carcinoma of the skin or in-situ carcinoma of the cervix
4. No previous chemotherapy
5. Normal bone marrow, renal and liver function
6. Patients must be randomised within 10 weeks of surgery
7. No medical contraindications to treatment
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
19/08/1993
Recruitment end date
31/12/2006
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
Research organisation
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
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? |
|---|