OSL Belly Board in patients receiving pelvic radiotherapy for rectal cancer
| ISRCTN | ISRCTN32235141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32235141 |
| Protocol serial number | N0013164858 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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 |
|---|---|
| stephen.l.morris@gstt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. The reproducibility of the patients position in our standard prone set up compared with that using the Belly Board |
| Key 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 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| 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
- United Kingdom
- England
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2016: Publication reference added
