Cervical Cancer
Conditions
Keywords
Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer
Brief 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.
Interventions
OTHERbrachytherapy
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.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder | 1 day | Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty. |
Secondary
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRENARD OLDRINI SOPHIE, MD
Institut de Cancérologie de Lorraine
Outcome results
None listed