Phase II Trial of Lung Chemoemobolization
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.
详细描述
PRIMARY OBJECTIVE:
I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.
OUTLINE:
Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy
- •Lung-dominant disease (majority of active tumor volume is in the chest)
- •At least 18 years old
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status > 2
- •Oxygen saturation < 92% on room air
- •Forced expiratory volume in 1 second (FEV1) < 60%
- •No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all < 1 cm)
- •Life expectancy < 6 months
- •Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [MRI], or direct pressure measurement)
- •Recent pulmonary embolism (within 3 months)
- •Pulmonary arteriovenous malformation
- •Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
- •Symptomatic heart failure (American College of Cardiology [ACC]/American Heart Association [AHA] stage C or D)
- •Left bundle branch block (contraindication to pulmonary angiography)
- •Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2)
- •Pregnancy or intent to become pregnant
- •Breast feeding
- •Altered mental status that would interfere with consent or follow-up
- •Platelets < 50,000 (after transfusion, if needed)
- •International normalized ratio (INR) > 2 (after transfusion, if needed)
- •Hemoglobin < 7 (after transfusion, if needed)
- •Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)
- •Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
- •Allergy to lipiodol or mitomycin
- •Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety
研究组 & 干预措施
Lung chemoembolization
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
干预措施: Computed Tomography (Procedure)
Lung chemoembolization
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
干预措施: Ethiodized Oil (Drug)
Lung chemoembolization
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
干预措施: Mitomycin (Drug)
Lung chemoembolization
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
干预措施: Transarterial Chemoembolization (Procedure)
Lung chemoembolization
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
干预措施: Tris-acryl Gelatin Microspheres (Device)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 3 months after the last chemoembolization procedure
Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.
Local progression free survival
时间窗: Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months
Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.
次要结局
- Lipiodol retention in treated tumors(4-6 weeks post-procedure)
- Growth of TACE targeted lesions versus non-TACE targeted lesions(4-6 weeks post-procedure)
- Progression-free survival(Up to 9 months)
- Overall survival(Up to 9 months)
- Objective response rate (best response)(Within 3 months of treatment)
- Bronchial versus pulmonary artery blood supply(Up to 9 months)