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
Conditions
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.
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.
Interventions
DRUGChemotherapy
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDUREMetastasectomy
Undergo lung metastasectomy
OTHERQuality-of-Life Assessment
Ancillary studies
PROCEDURETherapeutic Conventional Surgery
Undergo hepatectomy
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Survival | From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYun S Chun
M.D. Anderson Cancer Center
Participant flow
Recruitment details
29 patients were enrolled during 9/23/2016-8/29/2025 with 4 patient removed from study due to screen failure or withdrawal consent.
Pre-assignment details
8 patients were actual Arm-1 (surgery group): 5 randomly assigned as surgery; 3 randomly assigned as non-surgery but had surgery. 17 patients were actual Arm-2 (non-surgery): 14 randomly assigned as non-surgery; 3 randomly assigned as surgery but canceled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 8 | 12 / 17 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed