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

NCT ID: NCT04680715

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2028-06-30

Brief 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.

Conditions

Localized Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Per-Operative Radiotherapy technique by Papillon +TM

Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM

Group Type: EXPERIMENTAL

Per-Operative Radiotherapy technique by Papillon +TM

Intervention Type: RADIATION

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

Interventions

Per-Operative Radiotherapy technique by Papillon +TM

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pôle Santé République

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Centre Antoine Lacassagne

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frédérique JACQUINOT

Role: CONTACT

drci-promotion@nice.unicancer.fr

04 92 03 10 24 ext. +33

Facility Contacts

Annie ITIE

Role: primary

Damien CHAUVIERE

Role: primary

0492031365 ext. +33

Other Identifiers

2020/33

Identifier Type: -

Identifier Source: org_study_id