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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	OSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer
Study objectives	As 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) studied	Cancer: Rectal
Intervention	A 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 type	Other
Primary outcome measure	1. 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 measures	1. 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 date	01/03/2005
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	25 patients active (belly board) and 25 patients as controls.
Key inclusion criteria	50 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 criteria	Not meeting any of the inclusion criteria.
Date of first enrolment	01/03/2005
Date of final enrolment	30/09/2006

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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