Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Advanced Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma; Recurrent Adult Liver Carcinoma; Adult Hepatocellular Carcinoma
• Intervention / Treatment: Radiation: Stereotactic Radiosurgery

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 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (SBRT); Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.	Radiation: Stereotactic Radiosurgery; Undergo SBRT; Other Names: Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; Stereotactic Radiotherapy; stereotaxic radiation therapy; stereotaxic radiosurgery; Stereotactic Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Treatment-related Toxicity	The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	Within 3 months of SBRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Specific Survival (CSS)	Cancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.	Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years
Overall Survival (OS)	Overall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.	Time from study entry to death from any cause, assessed up to 2 years
Time to Local Progression (TTLP) of Treated Lesions	Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.	From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nitin Ohri, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2010
• Primary Completion (Actual): May 9, 2016
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimated): July 15, 2013

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 2010-326 (Other Identifier: Albert Einstein College of Medicine); P30CA013330 (U.S. NIH Grant/Contract)