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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
22
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.
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
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.
Time frame: 1 day
Non-inferiority based on the dose received by the rectum
Time frame: 1 day
Non-inferiority based on the dose received by the sigmoid
Time frame: 1 day
Non-inferiority based on the dose received by the small bowel
Time frame: 1 day
FIGO staging system
Time frame: 1 day
Body Mass Index
Time frame: 1 day
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