Contact information
Type
Scientific
Primary contact
Dr Stephen Morris
ORCID ID
Contact details
St Thomas' Hospital
Radiotherapy
Lambeth Wing
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 020 7188 1459
stephen.l.morris@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013164858
Study information
Scientific title
OSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
25 patients active (belly board) and 25 patients as controls.
Participant exclusion criteria
Not meeting any of the inclusion criteria.
Recruitment start date
01/03/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK), NHS R&D Support Funding
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
2014 results in http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=9402329&fileId=S1460396914000247