Status:
COMPLETED
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-ray...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To eva...
Eligibility Criteria
Inclusion
- Life expectancy \> 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- HCC diagnosed by either of the following approaches:
- Histologic confirmation of HCC on biopsy
- Evidence of vascular enhancement of suspected lesion on at least two imaging techniques
- Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is \> 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C
- HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon
- Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)
- Prior liver resection or ablative therapy is permitted
- Prior transarterial chemoembolization (TACE) is permitted
- Patients must have recovered from the effects of previous therapy
- Maximal tumor size of 15 cm and \> 700 cc of uninvolved liver
- Hemoglobin \> 9.0 g/L
- Absolute neutrophil count \>= 1.0 bil/L
- Platelets \>= 70,000 bil/L
- Total bilirubin \< 2 mg/dL
- International normalized ratio (INR) =\< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 6 times upper range of normal
Exclusion
- Active hepatitis or encephalopathy related to liver failure
- Prior radiation therapy to the upper abdomen or thorax
- Lesions within 1 cm from the stomach
- Prior uncontrolled, life threatening malignancy within the previous 6 months
- Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment
- Previous gastric, duodenal or variceal bleed within the past 2 months
- Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months
Key Trial Info
Start Date :
October 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01899261
Start Date
October 7 2010
End Date
May 1 2019
Last Update
November 29 2022
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461