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

January 28, 2026 updated by: Centre Antoine Lacassagne

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Pole Santé République
        • Contact:
          • Annie ITIE
        • Principal Investigator:
          • Vivien FUNG, Dr
      • Nice, France, 06189
        • Recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Damien CHAUVIERE
          • Phone Number: +33 0492031365
        • Principal Investigator:
          • Marie-Eve FOUCHE-CHAND, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Per-Operative Radiotherapy technique by Papillon +TM
Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
Radiation: Per-Operative Radiotherapy technique by Papillon +TM
20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
global tolerance of per-operative radiotherapy
Time Frame: up to 5 years
global safety (assessed by CTCAE V5.0) of per-operative radiotherapy
up to 5 years
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
up to 5 years
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
up to 5 years
quality of life of patients
Time Frame: up to 6 months
QLQ-C30 and QLQ BR-23 EORTC questionnaires
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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