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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01899261
Recruitment Status : Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : June 28, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nitin Ohri, Albert Einstein College of Medicine, Inc.

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-rays directly to the tumor and cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Adult Hepatocellular Carcinoma Advanced Adult Hepatocellular Carcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma Radiation: Stereotactic Radiosurgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
Actual Study Start Date : October 7, 2010
Actual Primary Completion Date : May 9, 2016
Estimated Study Completion Date : May 2019

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 Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

Primary Outcome Measures :
  1. 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 :
  1. CSS [ Time Frame: Time from study entry to death from HCC progression, assessed up to 2 years ]
    Competing risk analysis will be performed.

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

  3. 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 ]
  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01899261

United States, New York
Albert Einstein College of Medicine
The 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.

Responsible Party: Nitin Ohri, Principal Investigator, Albert Einstein College of Medicine, Inc. 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 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 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