Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer (RPOS+2)

Centre Antoine Lacassagne

Status and phase: Enrolling; Phase 2

Conditions: Localized Breast Cancer

Treatments: Radiation: Per-Operative Radiotherapy technique by Papillon +TM

Study type: Interventional

Funder types: Other

Identifiers

NCT04680715

2020/33

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Per-Operative Radiotherapy technique by Papillon +TM

Experimental group

Description:

Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM

Treatment:

Radiation: Per-Operative Radiotherapy technique by Papillon +TM