Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer
NCT ID: NCT02865837
Last Updated: 2018-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-09-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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ARM 1
brachytherapy
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.
Interventions
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brachytherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Institut de Cancérologie de Lorraine
OTHER
Responsible Party
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Principal Investigators
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RENARD OLDRINI SOPHIE, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de Lorraine
Locations
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Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2015-A00923-46
Identifier Type: -
Identifier Source: org_study_id
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