Clinical trial · Interventional
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer
A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer
NCT02880007CI-TRIAL-00124945TRIDICOLcompletedPhase 2ClinicalTrials.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)
This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.
Conditions
Conditions (4)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| PDR Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- Dose Optimization in 3D Pulsed Dose Rate Brachytherapy
- interventionNames
- Radiation: External Beam Radiation Therapy
- Radiation: PDR Brachytherapy
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Increase the local control rate
- timeFrame
- 24 months
- description
- Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms
Secondary outcomes (3)
- measure
- Maintain the cumulative rate grade III and IV complications below 6.5%
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * primitive cervical cancer * adenocarcinoma histologically advanced * IB2, II and III stage * curative treatment * indication of utero-vaginal brachytherapy with external radiotherapy * non-metastatic tumor and life expectancy \> 6 months * patient informed and follow possible * performance status ≤ 2 * unplanned surgery * age ≥ 18 years old * ability to provide written informed consent before the start of any study specific procedures Exclusion Criteria: * primitive endometrial cancer * other diseases * carcinoma in situ and stages ≤ B * distant metastases * history of pelvic irradiation or a first pelvic cancer * contraindication to MRI * history of subtotal or total hysterectomy * pregnant or breast feeding females * inability to support low dose rate continuous brachytherapy or pulsed flow * person in emergencies * person unable to give personally consent * patient participating in another clinical research except in case of local recurrence or observational research
References
Publications (1)
- BACKGROUNDCharra-Brunaud C, Salleron J, Menoux I, Peignaux K, Ducassou A, Petit A, Pommier P, Barillot I, Serre AA, Thomas L, Delannes M, Thibouw D, Antoni D, Renard S, Peiffert D. [Dose optimization in 3D pulsed dose rate brachytherapy for patients with locally advanced cervical cancer: A French multicenter phase II trial]. Cancer Radiother. 2022 May;26(3):474-480. doi: 10.1016/j.canrad.2021.06.030. Epub 2021 Jul 21. French. PMID 34301498