Clinical trial NCT00230347: Evaluation of Stereotactic Radiosurgery For Liver Malignancies
Official title: Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholangiocarcinoma
Liver Cancer
Adenocarcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response
measure: Practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique
measure: Safe dose for therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Albert Koong
role: PRINCIPAL_INVESTIGATOR
References: