Trials / Terminated

TerminatedNCT02738606

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

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 29 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
DRUG	Chemotherapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Metastasectomy	Undergo lung metastasectomy
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo hepatectomy

Timeline

Start date: 2016-09-23
Primary completion: 2025-12-05
Completion: 2025-12-05
First posted: 2016-04-14
Last updated: 2026-02-17
Results posted: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02738606. Inclusion in this directory is not an endorsement.