OSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer

ISRCTN ISRCTN32235141
DOI https://doi.org/10.1186/ISRCTN32235141
Secondary identifying numbers N0013164858
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
05/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Morris
Scientific

St Thomas' Hospital
Radiotherapy
Lambeth Wing
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone +44 020 7188 1459
Email stephen.l.morris@gstt.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer
Study objectivesAs part of our service development programme to improve patient immobilisation systems for the delivery of radiotherapy with new techniques we want to investigate a belly board system for our patients treated in the prone position for Rectal Cancer. The principle questions are whether the belly board will improve the reproducibility of the patient's position and reduce the amount of small bowel within the radiation fields.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: Rectal
InterventionA randomised trial designed to test the null hypothesis 'whether the Belly Board will improve the reproducibility of the patient's position and reduce the amount of small bowel within the radiation fields'.
25 patients will be randomised to be treated on the Board and 25 patients recruited as controls. Patients in the Belly Board arm of the study will need two CT scans, one on the Board to plan their treatment and one in the normal position so that the amount of small bowel in the radiation field can be compared within the same patient in the two different positions.
Intervention typeOther
Primary outcome measure1. The reproducibility of the patients position in our standard prone set up compared with that using the Belly Board
2. The small bowel volume within the radiation fields in our standard prone set up compared with that using the Belly Board
Secondary outcome measures1. To compare the patient comfort and ease of set up using our standard prone set up compared with that using the Belly Board
2. To compare the acute toxicity of radiotherapy delivered using our standard prone set up with that using the Belly Board
Overall study start date01/03/2005
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants25 patients active (belly board) and 25 patients as controls.
Key inclusion criteria50 patients who have histopathologically confirmed, resectable Rectal Adenocarcinoma who will be undergoing pelvic radiotherapy.

Inclusion criteria are:
1. Histopathology confirmed, resectable rectal adenocarcinoma
2. No prior pelvic radiotherapy
3. Staging CT Chest Abdomen and Pelvis excludes metastases
4. MRI staging T3/4 or N1 or T2 lower third rectal tumours
5. Age > 18
6. KPS > 70 and independently mobile to get onto the belly board
7. No contraindications to 5FU chemotherapy
8. Informed consent obtained
9. Subject able to fit into CT scanner on belly board
Key exclusion criteriaNot meeting any of the inclusion criteria.
Date of first enrolment01/03/2005
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK), NHS R&D Support Funding

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2014 Yes No

Editorial Notes

05/05/2016: Publication reference added