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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Other | 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. |
| 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 |
| 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 |
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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::
Ability to provide an informed written consent form
Patient must be affiliated to a social security system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RENARD OLDRINI SOPHIE, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28694116 | Result | Nesseler JP, Charra-Brunaud C, Salleron J, Py JF, Huertas A, Meknaci E, Courrech F, Peiffert D, Renard-Oldrini S. Effect of bladder distension on doses to organs at risk in Pulsed-Dose-Rate 3D image-guided adaptive brachytherapy for locally advanced cervical cancer. Brachytherapy. 2017 Sep-Oct;16(5):976-980. doi: 10.1016/j.brachy.2017.06.003. Epub 2017 Jul 8. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| 1 day |
| FIGO staging system | 1 day |
| Body Mass Index | 1 day |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |