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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02738606
Other study ID # 2015-1133
Secondary ID NCI-2016-0074020
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 25, 2016
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 29
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival The primary analysis will be performed in an intention-to-treat data set. Stratified log-rank test adjusting for the study stratification factors will be used to compare overall survival between the two treatment arms. The hazards ratio of overall survival for the surgery arm compared to the non-surgery arm will be estimated by fitting Cox proportional hazards regression models, adjusting for the effects of covariates including stratification factors. From the date of randomization to the date of death or the date of last follow-up, assessed up to 3 years
Secondary Incidence of adverse events Tabulated by frequency and percentages, by grade, and by their relations to surgical treatment. Up to 3 years
Secondary Extrahepatic and extrapulmonary metastases The Kaplan-Meier method will be used to estimate time to extrahepatic and extrapulmonary metastases. Up to 3 years
Secondary Intrahepatic recurrence The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence among patients randomized to surgery. Up to 3 years
Secondary 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
Secondary 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
Secondary Patients who abandon treatment Up to 3 years
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