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

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Yun S Chun · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-23

Primary Completion

2025-12-05

Completion

2025-12-05

FDA Drug

Yes

Countries

• United States

Study Locations