Evaluation of Stereotactic Radiosurgery For Liver Malignancies

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00230347
First received: September 28, 2005
Last updated: March 30, 2010
Last verified: March 2010

September 28, 2005
March 30, 2010
October 2003
January 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00230347 on ClinicalTrials.gov Archive Site
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Evaluation of Stereotactic Radiosurgery For Liver Malignancies
Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cholangiocarcinoma
  • Liver Cancer
  • Adenocarcinoma
Procedure: Stereotactic radiosurgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2007
January 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230347
HEP0003, HEP0003
Not Provided
Albert Koong, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Albert Koong Stanford University
Stanford University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP