Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer (RPOS+2)
Primary Purpose
Localized Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Per-Operative Radiotherapy technique by Papillon +TM
Sponsored by
About this trial
This is an interventional treatment trial for Localized Breast Cancer
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
Sites / Locations
- Pôle Santé République
- Centre Antoine LacassagneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Per-Operative Radiotherapy technique by Papillon +TM
Arm Description
Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
global tolerance of per-operative radiotherapy
global safety (assessed by CTCAE V5.0) of per-operative radiotherapy
local disease free survival at 5 years of per-operative radiotherapy
To evaluate local disease free survival at 5 years of per-operative radiotherapy
disease free survival at 5 years of per-operative radiotherapy
To evaluate disease free survival at 5 years of per-operative radiotherapy
quality of life of patients
QLQ-C30 and QLQ BR-23 EORTC questionnaires
Full Information
NCT ID
NCT04680715
First Posted
November 18, 2020
Last Updated
July 22, 2022
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT04680715
Brief Title
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Acronym
RPOS+2
Official Title
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
radiotherapy treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Per-Operative Radiotherapy technique by Papillon +TM
Arm Type
Experimental
Arm Description
Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
Intervention Type
Radiation
Intervention Name(s)
Per-Operative Radiotherapy technique by Papillon +TM
Intervention Description
20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
Primary Outcome Measure Information:
Title
early toxicities occuring until 6 months after performing per-operative radiotherapy
Description
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
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
global tolerance of per-operative radiotherapy
Description
global safety (assessed by CTCAE V5.0) of per-operative radiotherapy
Time Frame
up to 5 years
Title
local disease free survival at 5 years of per-operative radiotherapy
Description
To evaluate local disease free survival at 5 years of per-operative radiotherapy
Time Frame
up to 5 years
Title
disease free survival at 5 years of per-operative radiotherapy
Description
To evaluate disease free survival at 5 years of per-operative radiotherapy
Time Frame
up to 5 years
Title
quality of life of patients
Description
QLQ-C30 and QLQ BR-23 EORTC questionnaires
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédérique JACQUINOT
Phone
04 92 03 10 24
Ext
+33
Email
drci-promotion@nice.unicancer.fr
Facility Information:
Facility Name
Pôle Santé République
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie ITIE
First Name & Middle Initial & Last Name & Degree
Vivien FUNG, Dr
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien CHAUVIERE
Phone
0492031365
Ext
+33
First Name & Middle Initial & Last Name & Degree
Marie-Eve FOUCHE-CHAND, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
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