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Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald DeMatteo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-113

NCT ID:

NCT00028626

Start Date:

August 2001

Completion Date:

January 2004

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • liver metastases
  • adenocarcinoma of the colon
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the rectum
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021