Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Other: brachytherapy

• Registration Number: NCT02865837
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-07-04
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM 1	brachytherapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Non-inferiority based on the dose received by the rectum	1 day
Non-inferiority based on the dose received by the small bowel	1 day
Body Mass Index	1 day
Non-inferiority based on the dose received by the sigmoid	1 day
FIGO staging system	1 day

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-Nancy, France