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Not Recruiting
Trial ID: NCT00230347
Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Colleen Haas Chair in the School of Medicine
Inclusion Criteria:All the following criteria must be met:
- Liver tumors not to exceed 5 cm in diameter. If this size can be increased at all,
that would be beneficial as many liver lesions present at a larger size given the lack
of symptoms until they are larger and adequate hepatic function with albumin >3.0,
total bilirubin <3, INR 1.8. In the case of patients with known or 7 Dose Escalation
Study Evaluating Stereotactic Radiosurgery for Liver Malignancies suspected cirrhosis,
patients must have creatinine <1.5 and cannot have uncontrolled ascites,
encephalopathy, active or recent gastrointestinal bleed (GIB).
- Age > 18 years old
- Histologically confirmed hepatocellular carcinoma (HCC), intrahepatic
cholangiocarcinoma (IHCC), or metastatic adenocarcinoma of the breast/colon.
Metastatic tumors of other histologic types or sites of origin may be included if the
patients have a life expectancy of 6 months or greater. In the case of suspected HCC
in patients with known cirrhosis, noninvasive criteria recommended by the European
Association for the Study of Liver Diseases may be used. Hypervascular lesions > 2cm
with alpha-fetoprotein (AFP) > 400ng/mL or hypervascular lesions >2cm on at least 2
imaging studies.
- Unresectable disease as determined by a surgeon
- Eastern Clinical Oncology Group performance status 0,1 or 2
- No chemotherapy within 1 month of registration
- No prior radiotherapy to the liver or upper abdominal area
- Life expectancy > 6 months
- Patients with IHCC or HCC with distant metastasis are not eligible for this study.
- For colon cancer patients with metastatic tumor of the liver who are not amenable to
surgical resection due to the efficacy of removal of simultaneous lung and liver
metastasis. Exclusion Criteria:- Children are excluded because HCC, IHCC, and hepatic
metastases rarely occur in this age group. Furthermore, treatment requires a great
deal of patient cooperation including the ability to lie still for several hours in an
isolated room.
- No laboratory personnel will be included.
procedure: Stereotactic radiosurgery
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jeff Kim
6504987703