Brief Title
Evaluation of Stereotactic Radiosurgery For Liver Malignancies
Official Title
Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response
Condition
Cholangiocarcinoma
Intervention
Stereotactic radiosurgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
20
Start Date
October 2003
Completion Date
February 2007
Primary Completion Date
January 2007
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Albert Koong, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00230347
Organization ID
HEP0003
Secondary IDs
HEP0003
Study Sponsor
Stanford University
Study Sponsor
Albert Koong, Principal Investigator, Stanford University
Verification Date
March 2010