Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer

NCT03121469 | Completed DMC

• 1 other identifier: 2016/65
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1/2 study, open, monocenter, non-randomized

Conditions

Localized Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Technique of Per-Operative Radiotherapy feasability

  To evaluate the feasibility of performing an RPO delivering a satisfactory dose in the tumor excision bed measured using an in vivo dosimetry

  up to 3 years

Secondary Outcomes (3)

• Procedure tolerance

  up to 3 years

• Survival without local recurrence

  up to 3 years

• Application quality

  up to 3 years

Study Arms (1)

Per-Operative Radiotherapy

EXPERIMENTAL

Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM

Device: Papillon +TM

Interventions

Papillon +TM DEVICE

Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM

Per-Operative Radiotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with grade 1 or 2 invasive ductal adenocarcinoma or ductal carcinoma in situ, regardless of grade (found on mammography by an outbreak of Single microcalcification with a diameter not exceeding 2 cm or a tumor opacity \<2 cm),
• Patient aged 60 years or older (patients 60 years of age in the year may be included);
• Unilateral adenocarcinoma, unifocal, positive HR, non-overexpressed HER-2 - T1 N0 radio-clinical , Operable patient with breast volume compatible with conservative surgery,
• 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.

You may not qualify if:

• Age less than 60 years
• Patient with grade 3 invasive breast carcinoma
• Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
• Metastatic patient
• Multifocal and / or bilateral tumor
• N1 proved by ultrasound guided
• Patient with psychological and / or psychiatric disorders
• Vulnerable patient: a person deprived of liberty by an administrative or judicial decision, a major person who is the object of a legal protection measure or is unable to express his / her consent

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Study Officials

• Christine LOVERA, MRS

  Centre Antoine Lacassagne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 20, 2017
• Study Start: October 25, 2018
• Primary Completion: November 30, 2020
• Study Completion: June 10, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (1)