George Yang
Evaluation of Stereotactic Radiosurgery For Liver Malignancies
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Procedure: Stereotactic radiosurgery
Phase:
Phase 1Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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.
Additional Study Details
Official Title:
Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver MalignanciesAnticipated start date:
10/14/2003Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- Safe dose for therapy
- Practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique
- Efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- HEP0003
- NCT00230347
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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