Post-Operative Radiotherapy for Selected High Risk Rectal Adenocarcinoma

ISRCTN ISRCTN91411631
DOI https://doi.org/10.1186/ISRCTN91411631
Secondary identifying numbers GI/HRR
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedColorectal cancer
InterventionFollowing 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Northern and Yorkshire Clinical Trials and Research Unit (UK)
Research organisation

-
Leeds
-
United Kingdom

Funders

Funder type

Research organisation

Northern and Yorkshire Clinical Trials and Research Unit (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan