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

NCT02738606 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2015-1133NCI-2016-00740
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I (surgery, chemotherapy)

EXPERIMENTAL

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.

Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Metastasectomy; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery

Group II (chemotherapy)

ACTIVE COMPARATOR

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.

Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Metastasectomy; Other: Quality-of-Life Assessment

Interventions

Chemotherapy DRUG

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Group I (surgery, chemotherapy); Group II (chemotherapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (surgery, chemotherapy); Group II (chemotherapy)

Metastasectomy PROCEDURE

Undergo lung metastasectomy

Group I (surgery, chemotherapy); Group II (chemotherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (surgery, chemotherapy); Group II (chemotherapy)

Therapeutic Conventional Surgery PROCEDURE

Undergo hepatectomy

Group I (surgery, chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy; Metastasectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Yun Shin Chun
• Organization: The University of Texas MD Anderson Cancer Center

yschun@mdanderson.org

(713) 563-9682

Study Officials

• Yun S Chun

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 14, 2016
• Study Start: September 23, 2016
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Locations

US (1)