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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nitin Ohri, Albert Einstein College of Medicine of Yeshiva University Identifier:
First received: July 11, 2013
Last updated: January 23, 2017
Last verified: January 2017
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.

Condition Intervention
Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Localized Non-Resectable Adult Liver Carcinoma
Recurrent Adult Liver Carcinoma
Radiation: Stereotactic Radiosurgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma

Further study details as provided by Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • 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 ]
    The proportion of patients who have treatment-related toxicity will be computed, along with exact 95% confidence intervals.

Secondary Outcome Measures:
  • CSS [ Time Frame: Time from study entry to death from HCC progression, assessed up to 2 years ]
    Competing risk analysis will be performed.

  • OS [ Time Frame: Time from study entry to death from any cause, assessed up to 2 years ]
    Estimated by the Kaplan-Meier method.

  • 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 ]
  • TTLP [ Time Frame: Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years ]
    Estimated by the Kaplan-Meier method.

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

Detailed Description:


I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).


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.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01899261

United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
Principal Investigator: Nitin Ohri Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Nitin Ohri, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University Identifier: NCT01899261     History of Changes
Other Study ID Numbers: 20-10-326
NCI-2013-01126 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-10-326 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( US NIH Grant/Contract Award Number )
Study First Received: July 11, 2013
Last Updated: January 23, 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 21, 2017