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

NCT01842750 | Unknown

• 1 other identifier: 11_RADIO_101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• rectal volume

  patient scans will be reviewed over 4 weeks of radiotherapy

• Assessment of planning target volume (PTV) coverage

  patients will be reviewed across a 4 week radiotherapy treatment period.

• Rectal wall sparing

  patients reviewed across 4 weeks of radiotherapy treatment

• Acute toxicity

  patients toxicity will be assessed over 4 weeks of radiotherapy

Study Arms (1)

Endorectal Balloon insertion

EXPERIMENTAL

A cone Beam scan will be performed prior to balloon insertion and then again with balloon in situ. The scans will be compared to see if the organs are stabilised. Questionnaires will be completed by the radiographer and the patient.

Device: Endorectal Balloon insertion

Interventions

Endorectal Balloon insertion DEVICE

Endorectal Balloon insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

Christie Hospital NHS Foundation Trust

Manchester, Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Julie Stratford

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Stratford

CONTACT

01614463506; julie.stratford@christie.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research radiographer

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 30, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: July 30, 2014

Record last verified: 2014-06

Locations

GB (1)