Per-Operative Radiotherapy technique by Papillon +TM
Per-Operative Radiotherapy technique by Papillon +TM: 20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
Study 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
FEMALE
Min age
65 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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