The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Tolerability
时间窗: Patients will be assessed for 4 weeks throughout radiotherapy treatment
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.
次要结局
- Acute toxicity(patients toxicity will be assessed over 4 weeks of radiotherapy)
- Rectal wall sparing(patients reviewed across 4 weeks of radiotherapy treatment)
- 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.)
研究者
Julie Stratford
research radiographer
The Christie NHS Foundation Trust