Post-Operative Radiotherapy for Selected High Risk Rectal Adenocarcinoma
| ISRCTN | ISRCTN91411631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91411631 |
| Protocol serial number | GI/HRR |
| Sponsor | Northern and Yorkshire Clinical Trials and Research Unit (UK) |
| Funder | Northern and Yorkshire Clinical Trials and Research Unit (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 06/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
