Cryoablation vs Lumpectomy in T1 Breast Cancers

Официальное название

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in

Обзор

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.

Вмешательства

• Устройство Endocare 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
• Процедура Lumpectomy
  Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Первичные конечные точки

• Safety Lead-In: Number of treatment-related complications [Срок оценки: 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. [Срок оценки: At 5 years.]

Вторичные конечные точки (3)

• Proportion of patients who are free of serious treatment-related complications [Срок оценки: 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) [Срок оценки: Through 5 years.]
• Overall survival (OS) [Срок оценки: Through 5 years.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT05505643 · 202302017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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