Clinical trial · Interventional
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
NCT04680715CI-TRIAL-00101928RPOS+2recruitingPhase 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)
Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.
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 |
|---|---|---|---|
| Per-Operative Radiotherapy technique by Papillon +TM | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Per-Operative Radiotherapy technique by Papillon +TM
- description
- Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
- interventionNames
- Radiation: Per-Operative Radiotherapy technique by Papillon +TM
Primary outcomes (1)
- measure
- early toxicities occuring until 6 months after performing per-operative radiotherapy
- timeFrame
- up to 6 months
- description
- pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing
Secondary outcomes (4)
- measure
- global tolerance of per-operative radiotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with invasive ductal adenocarcinoma \<=2cm, evaluate on all radiological exams; * Women aged 65 years or older (patients 65 years of age in the year may be included); * Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status; * T0 or T1, N0 radio-clinic; * Operable patient with breast volume compatible with conservative surgery; * Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer * 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 65 years (except if 65 years obtained during the year) * Patient with an exclusive in situ carcinoma * Patient with lymphatic invasion / peri-nerve involvement / vascular emboli * Patient with a lobular adenocarcinoma * Patient with metastatic disease * Multifocal tumor * Patient with grade 3 or N+ disease * N1 proved by ultrasound guided * patient unable to express her consent * Patient deprived placed under the authority of a tutor * Female patients who are pregnant or breastfeeding * Vulnerable patient: as defined in article L1121-5 à -8
References
Publications (0)
Data not yet available
No reference posted for this study.