Clinical trial · Interventional
Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer
Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer
NCT02865837CI-TRIAL-00106677VESICOLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM 1
- interventionNames
- Other: brachytherapy
Primary outcomes (1)
- measure
- Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
- timeFrame
- 1 day
- description
- Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.
Secondary outcomes (5)
- measure
- Non-inferiority based on the dose received by the rectum
- timeFrame
- 1 day
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTNesseler 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 28694116