Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

Cervical Cancer Clinical Trial

— VESICOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865837
• Other study ID #: 2015-A00923-46
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Urinary Retention
• Uterine Cervical Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-inferiority based on the dose received by the rectum		1 day
Secondary	Non-inferiority based on the dose received by the sigmoid		1 day
Secondary	Non-inferiority based on the dose received by the small bowel		1 day
Secondary	FIGO staging system		1 day
Secondary	Body Mass Index		1 day