NCT02865837已完成不适用
Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer
Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
研究概览
简要总结
The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years old
- •with a cervical cancer histologically proven (squamous cell carcinoma, adenocarcinoma and neuroendocrine cell carcinoma)
- •Utero-vaginal brachytherapy indications::
- •Stage 1B1: brachytherapy before surgery
- •Stages IB2 to IIIB: after pelvic radiotherapy (45Gy/25 fractions/5 weeks) with or without concomitant chemotherapy
- •Ability to provide an informed written consent form
- •Patient must be affiliated to a social security system
排除标准
- •Age < 18 years old
- •History of pelvic radiotherapy
- •History of pelvic surgery
- •Recent joint prothesis (<3 months)
- •Pregnant woman or being breastfeeding
- •Patients deprived of liberty or under supervision
结局指标
主要结局
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
时间窗: 1 day
Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.
次要结局
- Non-inferiority based on the dose received by the rectum(1 day)
- Non-inferiority based on the dose received by the small bowel(1 day)
- Body Mass Index(1 day)
- Non-inferiority based on the dose received by the sigmoid(1 day)
- FIGO staging system(1 day)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Salvage Radiotherapy After Radical ProstatectomyProstate CancerNCT02597725University of Aarhus70
已完成
不适用
Relationship Between Bladder Distention and Hysteroscopy ApplicationMenorrhagiaNCT01848847Namik Kemal University102
已完成
不适用
The effect of reduced catheter-related bladder discomfort by intraoperative dexmedetomidine on postoperative pain sensation in patient undergoing microdiscectomyKCT0002369Hallym University Medical Center- Chuncheon76
已完成
不适用
Clinical Features and Histologic Findings in Bladder Pain Syndrome/Interstitial CystitisInterstitial Cystitis, ChronicPainful Bladder SyndromeNCT03069053Fondazione IRCCS Policlinico San Matteo di Pavia57
Unknown
不适用
Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract SurgeryCatheter-Related Bladder DiscomfortUrinary CatheterNCT06038448Buddhist Tzu Chi General Hospital120