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Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

Phase 1
18 Years
Not Enrolling
Cholangiocarcinoma, Liver Cancer, Adenocarcinoma

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Trial Information

Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response

Outcome Time Frame:


Safety Issue:


Principal Investigator

Albert Koong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

October 2003

Completion Date:

February 2007

Related Keywords:

  • Cholangiocarcinoma
  • Liver Cancer
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Liver Neoplasms
  • Cholangiocarcinoma



Stanford University School of MedicineStanford, California  94305-5317