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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01706016
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jean Remy GARBAY, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01706016     History of Changes
Other Study ID Numbers: 2012-A00448-35, 2011/1773
Study First Received: October 10, 2012
Last Updated: October 12, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 16, 2014