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Trial record 1 of 1 for:    NCT01706016
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Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1)

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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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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
U.S. FDA Resources

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



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



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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

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

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 Posted: October 15, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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