Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer (NCT02865837) | Clinical Trial Compass
CompletedNot Applicable
Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer
France22 participantsStarted 2015-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder