The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study

Prostate Cancer Clinical Trial

— BRAD  

Official title:

The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01842750
• Other study ID #: 11_RADIO_101
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2013
• Last updated: July 29, 2014
• Start date: August 2013

Study information

• Verified date: June 2014
• Source: Christie Hospital NHS Foundation Trust
• Contact: Julie Stratford
• Phone: 01614463506
• Email: julie.stratford[@]christie.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. In addition this study will test the hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years

• ECOG performance status 0-2 (Patients with PS-2 as a result of comorbidity will be excluded).

• Patients with histologically confirmed diagnosis of prostate adenocarcinoma

• Patients who are going to undergo treatment with radical radiotherapy for prostate cancer.

• Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent

• Patients must be able to comply with trial requirements.

Exclusion Criteria:

• Patients must not have a history of previous bowel surgery involving the rectum or anus.

• Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial, as well as any other serious uncontrolled medical condition.

• Any patient with a medical or psychiatric condition that impairs their ability to give informed consent

• Pre-existing anorectal disease, e.g. Haemorrhoids, active bleeding, anal irritation, inflammatory bowel disease.

• Patients who are unable to give consent.

• Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study.

• Prior pelvic radiotherapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• Endorectal Balloon insertion

Locations

Country	Name	City	State
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Christie Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	The primary aim is to determine whether the balloon insertion is tolerated throughout treatment. The principle outcome measure is the percentage of patients who tolerate the endorectal balloon throughout treatment.	Patients will be assessed for 4 weeks throughout radiotherapy treatment	No
Secondary	rectal volume	Rectal volume stability will be determined by comparing the rectal volume for scans with the endorectal balloon(ERB)in situ to scans without the ERB in situ	patient scans will be reviewed over 4 weeks of radiotherapy	No
Secondary	Assessment of planning target volume (PTV) coverage	PTV coverage and an assessment of prostate shape and position between the weekly imaging scans with the balloon in situ will be compared with the position of the prostate and PTV coverage on the original planning scan with the balloon in situ	patients will be reviewed across a 4 week radiotherapy treatment period.	No
Secondary	Rectal wall sparing	Rectal wall sparing will be assessed by comparing the estimated dose determined from the imaging scans with the ERB in situ and not in situ against the planned dose from the radiotherapy planning scan	patients reviewed across 4 weeks of radiotherapy treatment	No
Secondary	Acute toxicity	Acute toxicity according to CTCAE v. 4.0. This will record any reasons why balloon insertion is not possible for review.	patients toxicity will be assessed over 4 weeks of radiotherapy	No