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Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer (VESICOL)

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
brachytherapy
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer focused on measuring Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARM 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Non-inferiority based on the dose received by the rectum
Non-inferiority based on the dose received by the sigmoid
Non-inferiority based on the dose received by the small bowel
FIGO staging system
Body Mass Index

Full Information

First Posted
July 4, 2016
Last Updated
August 7, 2018
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02865837
Brief Title
Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer
Acronym
VESICOL
Official Title
Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
brachytherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
Description
Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Non-inferiority based on the dose received by the rectum
Time Frame
1 day
Title
Non-inferiority based on the dose received by the sigmoid
Time Frame
1 day
Title
Non-inferiority based on the dose received by the small bowel
Time Frame
1 day
Title
FIGO staging system
Time Frame
1 day
Title
Body Mass Index
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RENARD OLDRINI SOPHIE, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

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