Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 920
Study information
Scientific title
A pilot randomised trial comparing short course infusional 5-Fluorouracil (5FU) with 5FU + Leucovorin as adjuvant therapy for resected colorectal carcinoma
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
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
Colorectal carcinoma
Intervention
1. 5FU (Protracted venous infusion [PVI]) 12 weeks (300 mg/m2)
2. 5FU + Folinic Acid (NCCTG) (425 mg/m2 + 20 mg/m2) every 28 days for six courses
Intervention type
Drug
Phase
Not Applicable
Drug names
5-fluorouracil, leucovorin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/08/1993
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adenocarcinoma - Dukes stage B or C
2. No evidence of residual or metastatic disease assessed at surgery, clinically or radiologically
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
19/08/1993
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Hospital/treatment centre
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary