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NCT Number: NCT04680715

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pôle Santé République, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Per-Operative Radiotherapy technique by Papillon +TM

Radiation

20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

Primary outcomes

  1. early toxicities occuring until 6 months after performing per-operative radiotherapy

    Time frame: 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 outcomes

  1. global tolerance of per-operative radiotherapy

    Time frame: up to 5 years

    global safety (assessed by CTCAE V5.0) of per-operative radiotherapy

  2. local disease free survival at 5 years of per-operative radiotherapy

    Time frame: up to 5 years

    To evaluate local disease free survival at 5 years of per-operative radiotherapy

  3. disease free survival at 5 years of per-operative radiotherapy

    Time frame: up to 5 years

    To evaluate disease free survival at 5 years of per-operative radiotherapy

  4. quality of life of patients

    Time frame: up to 6 months

    QLQ-C30 and QLQ BR-23 EORTC questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Frédérique JACQUINOT

CONTACT

[email protected]

04 92 03 10 24 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study title

Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study

Acronym: RPOS+2

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Dec 23, 2020
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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