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

Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Stage IV Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7; Recurrent Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Lung; Resectable Colorectal Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Chemotherapy; Procedure: Metastasectomy; Procedure: Therapeutic Conventional Surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Drug: Chemotherapy; Other Names: Chemo; Chemotherapy (NOS); Chemotherapy, Cancer, General; Procedure: Metastasectomy; Undergo lung metastasectomy; Procedure: Therapeutic Conventional Surgery; Undergo hepatectomy
Active Comparator: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Drug: Chemotherapy; Other Names: Chemo; Chemotherapy (NOS); Chemotherapy, Cancer, General; Procedure: Metastasectomy; Undergo lung metastasectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Survival	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.	From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Tabulated by frequency and percentages, by grade, and by their relations to surgical treatment.	Up to 3 years
Extrahepatic and extrapulmonary metastases	The Kaplan-Meier method will be used to estimate time to extrahepatic and extrapulmonary metastases.	Up to 3 years
Intrahepatic recurrence	The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence among patients randomized to surgery.	Up to 3 years
Biomarker levels in blood and resected liver specimens	Univariate and multivariate Cox proportional hazards models will be fitted to evaluate the association between biomarkers in blood and resected liver specimens and time to event outcomes, including overall survival development of extrahepatic and extrapulmonary metastases, and time to intrahepatic recurrence among patients randomized to surgery. Univariate and multivariate logistic regression will be used to assess the association between biomarkers and response to chemotherapy	Up to 3 years
Scores of the Functional Assessment of Cancer Therapy - General 7 questionnaire	Summarized using descriptive statistics including mean, standard deviation, median, and range. Summation of item GP1, GP4, GP2, and GE6 (higher score indicates worse condition) and summation of GF5, GF3 and GF7 (higher score indicates better condition) will be calculated for each patient. Two sample t-tests will be used to compare scores of each item or summations between the two treatment arms.	Up to 3 years
Patients who abandon treatment		Up to 3 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Yun S Chun, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2016
• Primary Completion (Actual): December 5, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimated): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Therapeutics; Surgical Procedures, Operative; Drug Therapy; Metastasectomy
• Other Study ID Numbers: 2015-1133 (Other Identifier: M D Anderson Cancer Center); NCI-2016-00740 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No