We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706016
First Posted: October 15, 2012
Last Update Posted: June 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
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

Condition Intervention Phase
Breast Cancer Procedure: Thermic destruction of tissue by Laser using the Novilase device Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with breast cancer smaller than 20mm Procedure: Thermic destruction of tissue by Laser using the Novilase device

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706016


Contacts
Contact: Jean Remy GARBAY, MD +33 1 42 11 43 50 garbay@igr.fr
Contact: Ariane DUNANT +33 1 42 11 53 89 adunant@igr.fr

Locations
France
Centre Oscar Lambret Recruiting
Lille, Nord, France, 59000
Contact: Marie Pierre Chauvet, MD    0320295930 ext +33      
Principal Investigator: Marie Pierre Chauvet, MD         
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Jean Remy GARBAY, MD    +33 1 42 11 43 50    garbay@igr.fr   
Principal Investigator: Jean Remy GARBAY, MD         
Hopital Lariboisière Recruiting
Paris, France, 75010
Contact: Yann Delpech, MD    0149956236 ext +33      
Principal Investigator: Yann Delpech, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jean Remy GARBAY, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01706016     History of Changes
Other Study ID Numbers: 2012-A00448-35
2011/1773 ( Other Identifier: Institut Gustave Roussy )
First Submitted: October 10, 2012
First Posted: October 15, 2012
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases