Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2014 results in http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=9402329&fileId=S1460396914000247

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added