Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
- Conditions
- Localized Breast Cancer
- Interventions
- Radiation: Per-Operative Radiotherapy technique by Papillon +TM
- Registration Number
- NCT04680715
- Lead Sponsor
- Centre Antoine Lacassagne
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Per-Operative Radiotherapy technique by Papillon +TM Per-Operative Radiotherapy technique by Papillon +TM Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
- Primary Outcome Measures
Name Time Method early toxicities occuring until 6 months after performing per-operative radiotherapy up to 6 months 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 Outcome Measures
Name Time Method global tolerance of per-operative radiotherapy up to 5 years global safety (assessed by CTCAE V5.0) of per-operative radiotherapy
disease free survival at 5 years of per-operative radiotherapy up to 5 years To evaluate disease free survival at 5 years of per-operative radiotherapy
quality of life of patients up to 6 months QLQ-C30 and QLQ BR-23 EORTC questionnaires
local disease free survival at 5 years of per-operative radiotherapy up to 5 years To evaluate local disease free survival at 5 years of per-operative radiotherapy
Trial Locations
- Locations (2)
Pôle Santé République
🇫🇷Clermont-Ferrand, France
Centre Antoine Lacassagne
🇫🇷Nice, France