Clinical trial NCT02738606: 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
Official title: Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: From the date of randomization to the date of death or the date of last follow-up, assessed up to 3 years
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 3 years
measure: Extrahepatic and extrapulmonary metastases
timeFrame: Up to 3 years
measure: Intrahepatic recurrence
timeFrame: Up to 3 years
measure: Biomarker levels in blood and resected liver specimens
timeFrame: Up to 3 years
measure: Scores of the Functional Assessment of Cancer Therapy - General 7 questionnaire
timeFrame: Up to 3 years
measure: Patients who abandon treatment
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Yun S Chun
role: PRINCIPAL_INVESTIGATOR
References: