Cryoablation Versus Breast Surgery for Early-Stage Breast Cancer: SIX Trial Comparing Local Treatment and Costs

What this Trial Is About

Researchers are comparing cryoablation with breast surgery as local treatments for early-stage breast cancer (T1N0M0). This study aims to show that cryoablation is not less effective than surgery over five years while also analyzing the direct costs of both treatments during one year. Secondary goals include evaluating locoregional recurrence at one year, disease-free and overall survival over five years, and monitoring circulating tumor cells at several time points. Patient satisfaction and quality of life are also assessed using questionnaires. Participants receive either cryoablation, which involves destroying tumor tissue by freezing and thawing using a Cryoprobe guided by ultrasound under local anesthesia, or standard breast surgery (lumpectomy or mastectomy) under general anesthesia with sentinel lymph node biopsy. Cryoablation is a minimally invasive procedure without hospitalization, followed by adjuvant treatments including a preferred 5-fraction radiotherapy schedule if needed. Surgery patients also receive adjuvant treatment and radiotherapy as indicated. Axillary surgery is omitted in the cryoablation group. During the study, participants will be assessed for tumor recurrence, survival rates, circulating tumor cells, patient satisfaction, and quality of life through clinical evaluations and questionnaires. Follow-up spans five years for primary outcomes and includes a one-year cost comparison. The trial uses random assignment to treatment groups and involves safety monitoring and outcome tracking throughout the study period.

CRYoablation for Small Tumors As Local Treatment - SIX Trial