Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1<br> | Other: brachytherapy<br>* The brachytherapy applicator and a urinary catheter are set up in the operating room under general anesthesia. Then, an MRI (or a scanner if contra-indication) is performed after a bladder filling with 120cc of normal saline solution and urinary catheter clamping. Right after, a scanner is performed with urinary catheter declamping and emptied bladder. Delineation of CTVs and organs at risk (bladder, rectum, sigmoid, small bowel), and dosimetric optimisation are made on study with filled bladder. Then, organs at risk are delineated on the study with emptied bladder. The prior dosimetry is reset on this study and organs at risk doses are compared.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder | Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority based on the dose received by the rectum |  | 1 day | 
| Non-inferiority based on the dose received by the sigmoid |  | 1 day | 
| Non-inferiority based on the dose received by the small bowel |  | 1 day | 
| FIGO staging system |  | 1 day | 
| Body Mass Index |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer