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

Localized Breast Cancer Clinical Trial

— RPOS+2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04680715
• Other study ID #: 2020/33
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: June 2028

Study information

• Verified date: November 2023
• Source: Centre Antoine Lacassagne
• Contact: Frédérique JACQUINOT
• Phone: 04 92 03 10 24
• Email: drci-promotion[@]nice.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Localized Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Pôle Santé République	Clermont-Ferrand
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	global tolerance of per-operative radiotherapy	global safety (assessed by CTCAE V5.0) of per-operative radiotherapy	up to 5 years
Secondary	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
Secondary	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
Secondary	quality of life of patients	QLQ-C30 and QLQ BR-23 EORTC questionnaires	up to 6 months