Colon Cancer Clinical Trial
Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer
Summary
RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the portal vein on one side of the liver may cause the opposite side of the liver to increase in size and decrease the risk of liver failure following surgery.
PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer.
Full Description
OBJECTIVES:
Determine whether portal vein embolization results in significant hypertrophy of the remaining liver and potentially decreases the risk of liver failure after hepatic resection in patients with liver metastases from primary colorectal cancer.
Determine the biologic effects of this therapy on liver metastases and normal liver parenchyma in these patients.
OUTLINE: Patients undergo portal vein embolization with 200-300 micron polyvinyl chloride particles suspended in Iohexol 300. Approximately 3-6 weeks after embolization, patients undergo an exploratory laparotomy followed by hepatic surgical resection.
Patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary colorectal adenocarcinoma with metastases to the liver being considered for hepatic resection
Requirement for removal of at least 60% of functional liver parenchyma based on CT scan
No extrahepatic disease by laparoscopy
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
WBC at least 2,000/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than 1.8 mg/dL
AST and ALT no greater than 80 IU/L
Renal:
Creatinine no greater than 1.8 mg/dL
Cardiovascular:
No New York Heart Association class III or IV heart disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 1 month since prior systemic chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
Other:
At least 2 months since prior investigational treatment
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There is 1 Location for this study
New York New York, 10021, United States
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