|
ISRCTN
|
ISRCTN32235141
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
OSL Belly Board in patients receiving Pelvic Radiotherapy for Rectal cancer
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0013164858
|
|
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.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer: Rectal
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not meeting any of the inclusion criteria.
|
|
Anticipated start date
|
01/03/2005
|
|
Anticipated end date
|
30/09/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
25 patients active (belly board) and 25 patients as controls.
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
Guy's and St. Thomas' NHS Foundation Trust (UK), NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Stephen
Morris
|
|
Address
|
St Thomas' Hospital
Radiotherapy
Lambeth Wing
Lambeth Palace Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 7EH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 020 7188 1459
|
|
Fax
|
+44 020 7188 7188
|
|
Email
|
stephen.l.morris@gstt.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
28/09/2011
|
|
Date ISRCTN assigned
|
29/09/2006
|
