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Completed

NCT Number: NCT02865837

Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brachytherapy

Other

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 outcomes

  1. 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

  1. Non-inferiority based on the dose received by the rectum

    Time frame: 1 day

  2. Non-inferiority based on the dose received by the sigmoid

    Time frame: 1 day

  3. Non-inferiority based on the dose received by the small bowel

    Time frame: 1 day

  4. FIGO staging system

    Time frame: 1 day

  5. Body Mass Index

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: VESICOL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2016
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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