RecruitingPhase 2NCT04680715
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
Sponsor
Centre Antoine Lacassagne
Enrollment
40 participants
Start Date
Jul 16, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 65 Years
Inclusion Criteria8
- 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 Criteria12
- 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
Interventions
RADIATIONPer-Operative Radiotherapy technique by Papillon +TM
20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04680715