Local Treatment by Thermic Destruction of Primitive Breast Cancer
Phase 2
Completed
- Conditions
- Breast Cancer
- Interventions
- Procedure: Thermic destruction of tissue by Laser using the Novilase device
- Registration Number
- NCT01706016
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with breast cancer smaller than 20mm Thermic destruction of tissue by Laser using the Novilase device -
- Primary Outcome Measures
Name Time Method Effectiveness of laser treatment 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
Name Time Method Life quality D-0 and before the surgery Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3
Trial Locations
- Locations (3)
Institut Gustave Roussy
🇫🇷Villejuif, Val De Marne, France
Centre Oscar Lambret
🇫🇷Lille, Nord, France
Hopital Lariboisière
🇫🇷Paris, France