Local Treatment by Thermic Destruction of Primitive Breast Cancer

Gustave Roussy, Cancer Campus, Grand Paris16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Thermic destruction of tissue by Laser using the Novilase devicePROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Oscar Lambret

Lille, Nord, France

Institut Gustave Roussy

Villejuif, Val De Marne, France

Hopital Lariboisière

Paris, France

Outcomes

Primary Outcomes

Effectiveness of laser treatment

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

Time frame: 28 days after initial diagnosis

Secondary Outcomes

Life quality

Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3

Time frame: D-0 and before the surgery

Data from ClinicalTrials.gov

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