We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01706016
Previous Study | Return to List | Next Study

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706016
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: Thermic destruction of tissue by Laser using the Novilase device Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
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.
Actual Study Start Date : October 9, 2012
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : November 17, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
France
Centre Oscar Lambret
Lille, Nord, France, 59000
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805
Hopital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Layout table for investigator information
Principal Investigator: Jean Remy GARBAY, MD Gustave Roussy, Cancer Campus, Grand Paris
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01706016    
Other Study ID Numbers: 2012-A00448-35
2011/1773 ( Other Identifier: Institut Gustave Roussy )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases