Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
This trial is active, not recruiting.
|Conditions||adult hepatocellular carcinoma, advanced adult hepatocellular carcinoma, localized non-resectable adult liver carcinoma, recurrent adult liver carcinoma|
|Sponsor||Albert Einstein College of Medicine of Yeshiva University|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2010|
|End date||December 2016|
|Trial size||20 participants|
|Trial identifier||NCT01899261, 20-10-326, 2010-326, NCI-2013-01126, P30CA013330, SLI|
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-rays directly to the tumor and cause less damage to normal tissue.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Treatment-related toxicity defined as grade 4 or 5 hepatic, thrombocytopenic, or gastrointestinal toxicity graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
time frame: Within 3 months of SBRT
time frame: Time from study entry to death from HCC progression, assessed up to 2 years
time frame: Time from study entry to death from any cause, assessed up to 2 years
Response rate defined as proportion of patients achieving a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Up to 6 months after completion of SBRT
time frame: Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 A or B required (i.e., unresectable early or intermediate 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 >= 50,000 bil/L - Bilirubin =< 4 times upper range of normal - 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 Criteria: - 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
|Official title||A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma|
|Principal investigator||Nitin Ohri|
|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 evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT. II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT. III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field. OUTLINE: Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.|
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