Evaluation of Stereotactic Radiosurgery For Liver Malignancies

Phase 1

Completed

• Conditions: Cholangiocarcinoma; Liver Cancer; Adenocarcinoma

• Registration Number: NCT00230347
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-30
• Primary Completion: 2007-01
• Study Completion: 2007-02
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-30
• Last Update Posted: 2010-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response
Practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique
Safe dose for therapy

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States