NCT02865837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

July 4, 2016

Last Update Submit

March 23, 2026

Conditions

Cervical Cancer

Keywords

BrachytherapyOrgans at RiskBladder volumeCervical cancer

Outcome Measures

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.

    1 day

Secondary Outcomes (5)

  • Non-inferiority based on the dose received by the rectum

    1 day

  • Non-inferiority based on the dose received by the sigmoid

    1 day

  • Non-inferiority based on the dose received by the small bowel

    1 day

  • FIGO staging system

    1 day

  • Body Mass Index

    1 day

Study Arms (1)

ARM 1

EXPERIMENTAL
Other: brachytherapy

Interventions

brachytherapyOTHER

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.

ARM 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

  • 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.

    PMID: 28694116RESULT

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • RENARD OLDRINI SOPHIE, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

August 15, 2016

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)