Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer

Last updated: January 17, 2025
Sponsor: Centre Antoine Lacassagne
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Per-Operative Radiotherapy technique by Papillon +TM

Clinical Study ID

NCT04680715
2020/33
  • Ages > 65
  • Female

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient with invasive ductal adenocarcinoma <=2cm, evaluate on all radiologicalexams;

  • 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 HER2status;

  • 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 theirwritten signed informed consent;

  • Patients benefitting from social health insurance coverage

Exclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Per-Operative Radiotherapy technique by Papillon +TM
Phase: 2
Study Start date:
July 16, 2021
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Pôle Santé République

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

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