Clinical trial NCT01842750: The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study
Official title: The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerability
timeFrame: Patients will be assessed for 4 weeks throughout radiotherapy treatment
Secondary outcomes:
measure: rectal volume
timeFrame: patient scans will be reviewed over 4 weeks of radiotherapy
measure: Assessment of planning target volume (PTV) coverage
timeFrame: patients will be reviewed across a 4 week radiotherapy treatment period.
measure: Rectal wall sparing
timeFrame: patients reviewed across 4 weeks of radiotherapy treatment
measure: Acute toxicity
timeFrame: patients toxicity will be assessed over 4 weeks of radiotherapy
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Julie Stratford
role: PRINCIPAL_INVESTIGATOR
References: