COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
Summary
This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.
Arms & interventions
- DeviceEndocare SlimLine Cryoprobe
The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.
- ProcedureLumpectomy
Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Outcome measures
Primary
Safety Lead-In: Number of treatment-related complications
Excessive adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. They are defined as toxicities occurring within 30 days after the cryoablation procedure and are at least possibly related to the cryoablation. These include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or complications related to cryoablation which interfere with adjuvant therapy such that the adjuvant therapy cannot be performed at all or delayed for a period longer than 6 months or which result in unplanned mastectomy.
Time frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
IBTR defined from date of procedure to date of ipsilateral breast cancer recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event and patients will be censored at the last follow-up.
Time frame: At 5 years.
Secondary
Proportion of patients who are free of serious treatment-related complications
Time frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
Proportion of patients who demonstrate disease-free survival (DFS)
Time frame: Through 5 years.
Overall survival (OS)
Time frame: Through 5 years.
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110