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

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

- Patients with histologically confirmed diagnosis of prostate adenocarcinoma

- Patients who are going to undergo treatment with radical radiotherapy for prostate

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

Patients will be assessed for 4 weeks throughout radiotherapy treatment

Safety Issue:


Principal Investigator

Julie Stratford

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie Hospital NHS Foundation Trust


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms