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
NCT ID: NCT02738606
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
28 participants
INTERVENTIONAL
2016-05-25
2025-12-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Chemotherapy
Laboratory Biomarker Analysis
Correlative studies
Metastasectomy
Undergo lung metastasectomy
Quality-of-Life Assessment
Ancillary studies
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.
Therapeutic Conventional Surgery
Undergo hepatectomy
Chemotherapy
Laboratory Biomarker Analysis
Correlative studies
Metastasectomy
Undergo lung metastasectomy
Quality-of-Life Assessment
Ancillary studies
Interventions
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Therapeutic Conventional Surgery
Undergo hepatectomy
Chemotherapy
Laboratory Biomarker Analysis
Correlative studies
Metastasectomy
Undergo lung metastasectomy
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yun S Chun
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2016-00740
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-1133
Identifier Type: OTHER
Identifier Source: secondary_id
2015-1133
Identifier Type: -
Identifier Source: org_study_id