OSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer
ISRCTN | ISRCTN32235141 |
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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
Scientific
St Thomas' Hospital
Radiotherapy
Lambeth Wing
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Phone | +44 020 7188 1459 |
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stephen.l.morris@gstt.nhs.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
SE1 7EH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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? |
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Results article | results | 01/12/2014 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added