Evaluation of Stereotactic Radiosurgery For Liver Malignancies

Liver Cancer Clinical Trial

Official title:

Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230347
• Other study ID #: HEP0003
• Secondary ID: HEP0003
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2005
• Last updated: March 30, 2010
• Start date: October 2003
• Est. completion date: February 2007

Study information

• Verified date: March 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cholangiocarcinoma
• Liver Cancer

Intervention

Procedure:
• Stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response		unknown	No
Primary	Practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique		unknown	No
Primary	Safe dose for therapy		unknown	Yes