Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GI/HRR
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
Colorectal cancer
Intervention
Following surgery patients are randomised to one of two treatment arms:
1. Arm A: Post-operative radiotherapy, a midplane dose of 45 Gy given over 4 to 5 weeks
2. Arm B: No radiotherapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically proven adenocarcinoma of the rectum
2. Surgery at or below pelvic brim
3. Curative operation, all macroscopic disease removed
4. Aged <80 years, 75 years if physically unfit
5. No previous history of multiple abdominal or pelvic surgical procedures
6. No evidence of small bowel descending into area of maximum dose of radiotherapy
7. Adequate bone marrow function
Participant type
Patient
Age group
Adult
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
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Northern and Yorkshire Clinical Trials and Research Unit (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
Basic results (scientific)
Publication list