Actively Recruiting
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer: Feasibility and Toxicity Study
Led by Centre Antoine Lacassagne · Updated on 2026-01-29
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of using per-operative radiotherapy with the Papillon +TM device in women aged 65 years and older who have localized breast cancer. This Phase II study is designed to understand early toxicities following this treatment and assess its overall tolerance and impact on quality of life over time. Participants will receive a single 20Gy dose of per-operative radiotherapy delivered with the Papillon +TM device during breast-conserving surgery. This approach is focused on treating localized invasive ductal adenocarcinoma that meets specific size and grading criteria. The study monitors patients for up to five years to evaluate disease-free survival and long-term treatment tolerance. Throughout the study, participants will undergo regular assessments to monitor early toxicities for up to six months after treatment and quality of life evaluations. Researchers will also track local and overall disease-free survival for up to five years. The total participation duration includes close follow-up to ensure safety and gather comprehensive data on the treatment's effects.
CONDITIONS
Brief Title
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 65 years or older (patients 65 years of age in the year may be included)
- Patient with invasive ductal adenocarcinoma 2 cm or smaller, evaluated on all radiological exams
- Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive hormone receptor, negative HER2 status
- T0 or T1, N0 radiological and clinical status
- Operable patient with breast volume compatible with conservative surgery
- Patient with prior or concurrent malignancies, including bilateral breast cancer, are eligible
- Patients who have given written informed consent after being informed
- Patients covered by social health insurance
You will not qualify if you...
- Age less than 65 years (except if 65 years obtained during the year)
- Patient with exclusive in situ carcinoma
- Patient with lymphatic invasion, peri-nerve involvement, or vascular emboli
- Patient with lobular adenocarcinoma
- Patient with metastatic disease
- Multifocal tumor
- Patient with grade 3 or N+ disease
- N1 disease confirmed by ultrasound-guided biopsy
- Patient unable to provide consent
- Patient under legal guardianship or tutorship
- Female patients who are pregnant or breastfeeding
- Vulnerable patients as defined by legal protections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single session of per-operative radiotherapy (20Gy) using the Papillon +TM technique for localized breast cancer.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for early toxicities, quality of life, and disease outcomes following treatment.
Visits periodically over 6 months to 5 years
Trial Site Locations
Total: 2 locations
1
Pôle Santé République
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
Research Team
F
Frédérique JACQUINOT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here