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

Stopped early · Phase 2

Conditions studied: Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Recurrent Colorectal Carcinoma, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7

In brief

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.

Key facts

Study ID: NCT02738606
Run by: M.D. Anderson Cancer Center
People needed: 29
Starts: 2016-09-23
Expected to finish: 2025-12-05
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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