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Clinical Trials/NCT02865837
NCT02865837CompletedNot Applicable

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

Institut de Cancérologie de Lorraine2 sites in 1 country22 target enrollmentStarted: September 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
22
Locations
2
Primary Endpoint
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder

Time Frame: 1 day

Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Institut de Cancérologie de Lorraine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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