Evaluation of Stereotactic Radiosurgery For Liver Malignancies

Not Recruiting

Trial ID: NCT00230347


This study is intended to establish the practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique. A second purpose is to establish a safe dose for such therapy. Finally, the efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response, will be measured.

Official Title

Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Iris C. Gibbs, MD, FACR, FASTRO
Iris C. Gibbs, MD, FACR, FASTRO

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

George A. Fisher Jr.
George A. Fisher Jr.

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

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jeff Kim

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