Trials Sponsors Conditions Drugs Pricing

Conditions

Localized Breast Cancer

Outcome Measures

Primary Outcomes (2)

In Vivo Measurement of the Delivered Radiation Dose During Intraoperative Radiotherapy (IORT).
Assesses the absorbed radiation dose delivered to the tumor bed cavity during surgery. In vivo dosimetry measurements are recorded at two distinct anatomical locations relative to the spherical applicator surface: the south pole and the equator. Data will be reported as the mean value and standard deviation (SD) in Gray (Gy) for each measurement site.
Days 1 during per-Operative radiotherapy
Number of Participants With a Compliant Delivered Radiation Dose by Measurement Location.
Assesses treatment conformity relative to the prescribed dose of 20 Gray (Gy). A delivered dose is defined as compliant if it reaches at least 80% of the prescription (i.e., $\\ge$ 16 Gy). In vivo measurements are evaluated independently at two locations (south pole and equator). Data will be reported as the number (and percentage) of participants achieving this 16 Gy compliance threshold at each site.
During surgery (at the time of intraoperative radiotherapy delivery).

Secondary Outcomes (4)

In Vivo Measurement of the Radiation Dose Delivered to the Skin.
During surgery (at the time of intraoperative radiotherapy delivery).
Number of Participants With a Compliant Skin Radiation Dose by Dosimeter Site.
During surgery (at the time of intraoperative radiotherapy delivery).
5-year Local Relapse-Free Survival (LRFS) Rate.
up to 5 years
Surgical Assessment of Applicator Coverage Within the Tumor Bed.
During surgery (at the time of applicator placement).

Study Arms (1)

Per-Operative Radiotherapy

EXPERIMENTAL

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

Device: Papillon +TM

Interventions

Papillon +TMDevice

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

Per-Operative Radiotherapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age60 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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);

Sponsors & Collaborators

Centre Antoine Lacassagne
Otherlead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Results Point of Contact

Title: Director of Clinical Trials
Organization: Centre Antoine lacassagne

Study Officials

Christine LOVERA, MRS
Centre Antoine Lacassagne
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

28 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Per-Operative Radiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Per-Operative Radiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations