Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Participants With Survival
研究概览
简要总结
This randomized phase II trial studies how well liver surgery and chemotherapy compared to chemotherapy alone work in treating patients with colorectal cancer that has spread to the liver (liver metastases) that can be removed by surgery and that has spread to the lungs (lung metastases) that cannot be removed by surgery. Liver surgery removes a portion of the liver affected by the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liver surgery and chemotherapy may work better than chemotherapy alone in treating patients with colorectal cancer which has spread to the liver and lungs.
详细描述
PRIMARY OBJECTIVE:
I. To determine a survival benefit of liver resection in patients with resectable liver and unresectable low-volume pulmonary metastases from colorectal cancer.
SECONDARY OBJECTIVES:
I. To identify biomarkers in blood and resected liver specimens that correlate with survival, and development of extrahepatic and extrapulmonary metastases.
II. To assess patients' quality-of-life in each treatment arm with serial questionnaires.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with synchronous or metachronous diagnosis of resectable liver metastases by computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen
- •Patients requiring percutaneous or intraoperative ablation of liver metastases < 2 cm in size are eligible
- •Patients who underwent prior liver resection or ablation for colorectal liver metastases are eligible
- •Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible
- •The primary tumor in the colon or rectum may be intact or resected
- •Low-volume lung metastases are defined as solid pulmonary nodules < 2 cm with non-spiculated contours, no benign-appearing calcifications, and =< 14 in number, diagnosed by computed tomography of the chest or positron emission tomography (PET)
- •Lung metastases will be unresectable due to anatomic location, distribution, or patients' comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic & Cardiovascular Surgery
- •Patients must sign a study-specific consent form
- •Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung and liver metastases within 60 days of registration; for patients who cannot tolerate CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the liver will be performed
排除标准
- •Radiographic evidence of disease other than liver and lungs, with the exception of mediastinal lymph nodes < 2 cm and hepatoduodenal ligament lymphadenopathy, diagnosed by computed tomography, magnetic resonance imaging, or positron emission tomography
- •Serum bilirubin >= 2 mg/dL
- •Platelet count < 50,000/uL
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3-4
- •Patient refusal to participate in randomization
- •Pregnant women are excluded from this study
- •Planned stereotactic body radiation therapy (SBRT) for the pulmonary metastases
研究组 & 干预措施
Group I (surgery, chemotherapy)
Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Metastasectomy (Procedure)
Group I (surgery, chemotherapy)
Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Chemotherapy (Drug)
Group I (surgery, chemotherapy)
Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (surgery, chemotherapy)
Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Quality-of-Life Assessment (Other)
Group I (surgery, chemotherapy)
Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Therapeutic Conventional Surgery (Procedure)
Group II (chemotherapy)
Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Chemotherapy (Drug)
Group II (chemotherapy)
Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (chemotherapy)
Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Metastasectomy (Procedure)
Group II (chemotherapy)
Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Number of Participants With Survival
时间窗: From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months
The survival subjects were monitored with protocol defined period --- 3 years after enrollment. Survival counts each Arm (percent of survival rate) and p value of Chi-square test for survival rate comparison are shown.
次要结局
未报告次要终点