Evaluation of Stereotactic Radiosurgery For Liver Malignancies - Full Text View

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00230347

Purpose

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.

Condition	Intervention	Phase
Cholangiocarcinoma Liver Cancer Adenocarcinoma	Procedure: Stereotactic radiosurgery	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response [ Time Frame: unknown ] [ Designated as safety issue: No ]
Practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique [ Time Frame: unknown ] [ Designated as safety issue: No ]
Safe dose for therapy [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2003
Study Completion Date:	February 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230347

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Albert Koong

Stanford University

More Information

No publications provided

Responsible Party:	Albert Koong, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00230347 History of Changes
Other Study ID Numbers:	HEP0003, HEP0003
Study First Received:	September 28, 2005
Last Updated:	March 30, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Adenocarcinoma
Neoplasms
Liver Neoplasms
Cholangiocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on February 13, 2012