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CompletedNCT02865837VESICOLUpdated Mar 27, 2026

Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

An interventional study of brachytherapy in Cervical Cancer, sponsored by Institut de Cancérologie de Lorraine. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2015, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Cervical Cancer

Keywords

  • Brachytherapy
  • Organs at Risk
  • Bladder volume
  • Cervical cancer
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    ARM 1

    Other: brachytherapy

Interventions

  • Otherbrachytherapy

    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.

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What researchers measure

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

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

    Time frame: 1 day

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

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Study locations

1 site
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, 54500, France
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References and documents

Publications

  • Nesseler JP, Charra-Brunaud C, Salleron J, Py JF, Huertas A, Meknaci E, Courrech F, Peiffert D, Renard-Oldrini S. Effect of bladder distension on doses to organs at risk in Pulsed-Dose-Rate 3D image-guided adaptive brachytherapy for locally advanced cervical cancer. Brachytherapy. 2017 Sep-Oct;16(5):976-980. doi: 10.1016/j.brachy.2017.06.003. Epub 2017 Jul 8. PubMed 28694116 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02865837
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Aug 15, 2016
Start date
Sep 2015
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Mar 27, 2026

Study contacts

RENARD OLDRINI SOPHIE, MD
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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