Clinical trial · Interventional
Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer
NCT03121469CI-TRIAL-00116646RPOS+completedN/AResults postedClinicalTrials.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)
Phase 1/2 study, open, monocenter, non-randomized
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 |
|---|---|---|---|
| Localized Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Papillon +TM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Per-Operative Radiotherapy
- description
- Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM
- interventionNames
- Device: Papillon +TM
Primary outcomes (2)
- measure
- In Vivo Measurement of the Delivered Radiation Dose During Intraoperative Radiotherapy (IORT).
- timeFrame
- Days 1 during per-Operative radiotherapy
- description
- Assesses the absorbed radiation dose delivered to the tumor bed cavity during surgery. In vivo dosimetry measurements are recorded at two distinct anatomical locations relative to the spherical applicator surface: the south pole and the equator. Data will be reported as the mean value and standard deviation (SD) in Gray (Gy) for each measurement site.
- measure
- Number of Participants With a Compliant Delivered Radiation Dose by Measurement Location.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with grade 1 or 2 invasive ductal adenocarcinoma or ductal carcinoma in situ, regardless of grade (found on mammography by an outbreak of Single microcalcification with a diameter not exceeding 2 cm or a tumor opacity \<2 cm), * Patient aged 60 years or older (patients 60 years of age in the year may be included); * Unilateral adenocarcinoma, unifocal, positive HR, non-overexpressed HER-2 - T1 N0 radio-clinical , Operable patient with breast volume compatible with conservative surgery, * Patients who have been made aware of the information sheet and have given their written signed informed consent. * Patients benefitting from social health insurance coverage. Exclusion Criteria: * Age less than 60 years * Patient with grade 3 invasive breast carcinoma * Patient with lymphatic invasion / peri-nerve involvement / vascular emboli * Metastatic patient * Multifocal and / or bilateral tumor * N1 proved by ultrasound guided * Patient with psychological and / or psychiatric disorders * Vulnerable patient: a person deprived of liberty by an administrative or judicial decision, a major person who is the object of a legal protection measure or is unable to express his / her consent
References
Publications (0)
Data not yet available
No reference posted for this study.