Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
M.D. Anderson Cancer Center
With
National Cancer Institute (NCI)
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.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: 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.
GROUP II: 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.
Patients are followed up every 3-6 months up to 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery
