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

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: Recruiting
• Conditions: Localized Breast Cancer
• Intervention / Treatment: Radiation: Per-Operative Radiotherapy technique by Papillon +TM

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédérique JACQUINOT; Phone Number: +33 04 92 03 10 24; Email: drci-promotion@nice.unicancer.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Pôle 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
early toxicities occuring until 6 months after performing per-operative radiotherapy	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

Outcome Measure	Measure Description	Time Frame
global tolerance of per-operative radiotherapy	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	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	To evaluate disease free survival at 5 years of per-operative radiotherapy	up to 5 years
quality of life of patients	QLQ-C30 and QLQ BR-23 EORTC questionnaires	up to 6 months

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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