Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1)

March 27, 2018 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscar Lambret
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Noninflammatory unilateral and unifocal breast cancer
  • Size </= 20mm (ultrasound measure)
  • Histological confirmation of cancer by biopsy grade status hormone and HER2.
  • Good delineation of the lesion on ultrasound.
  • Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
  • Age between 18 and 80
  • ECOG performance status 0 or 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with breast cancer smaller than 20mm
Procedure: Thermic destruction of tissue by Laser using the Novilase device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of laser treatment
Time Frame: 28 days after initial diagnosis

Destruction of the carcinoma will be assess by histological analysis of the specimen.

If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail
28 days after initial diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality
Time Frame: D-0 and before the surgery
Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3
D-0 and before the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Jean Remy GARBAY, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2012

Primary Completion (Actual)

November 17, 2016

Study Completion (Actual)

November 17, 2016

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00448-35
  • 2011/1773 (Other Identifier: Institut Gustave Roussy)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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