COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).
- •If DCIS is present in the biopsy specimen it should be <25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).
- •Oncotyping will be performed on T1b+Allred<6/8 and T1c tumors. Oncotype score in this subset of patients must be <26 to be included in the trial.
- •At least 50 years of age.
- •Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Indication for neoadjuvant chemotherapy.
- •Prior history of breast cancer.
- •Breast augmentation.
- •Allergy to local anesthetics.
- •Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- •Tumoral involvement of skin or chest wall.
研究组 & 干预措施
Cryoablation
Patients will be treated with cryoablation using the Endocare SlimLine Cyroprobe under real time ultrasound guidance and local anesthesia. The cryoablation consists of a 10 minute freeze phase followed by a 10 minute passive thaw, and ends with a second 10 minute freeze cycle. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size.
干预措施: Endocare SlimLine Cryoprobe (Device)
Lumpectomy
Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.
干预措施: Lumpectomy (Procedure)
Rescue Arm: Lumpectomy
If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI (if can tolerate) and yearly MRI/mammography), patients in the cryoablation safety lead-in and who were randomized to receive cryoablation only will be crossed over to receive a rescue lumpectomy followed by adjuvant treatment based on standard of care.
干预措施: Lumpectomy (Procedure)
Cryoablation - Safety Lead In
Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.
干预措施: Endocare SlimLine Cryoprobe (Device)
结局指标
主要结局
Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
时间窗: At 5 years.
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.
Safety Lead-In: Number of treatment-related complications
时间窗: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
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.
次要结局
- Overall survival (OS)(Through 5 years.)
- Proportion of patients who are free of serious treatment-related complications(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)(Through 5 years.)