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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01899261
First received: July 11, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Radiation: stereotactic body radiation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

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 ] [ Designated as safety issue: Yes ]
    The proportion of patients who have treatment-related toxicity will be computed, along with exact 95% confidence intervals.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • TTLP [ Time Frame: Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method.

  • CSS [ Time Frame: Time from study entry to death from HCC progression, assessed up to 2 years ] [ Designated as safety issue: No ]
    Competing risk analysis will be performed.

  • OS [ Time Frame: Time from study entry to death from any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method.


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT-stereotactic body radiation therapy
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899261

Locations
United States, New York
Albert Einstein College of Medicine/Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Chandan Guha    718-920-4361    cguha@montefiore.org   
Contact: Kristin Fallon-Hanley, MBA    718-904-2529    cpdmu@montefiore.og   
Principal Investigator: Chandan Guha         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Chandan Guha Albert Einstein College of Medicine/Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01899261     History of Changes
Other Study ID Numbers: 2010-326, NCI-2013-01126, SLI, P30CA013330
Study First Received: July 11, 2013
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on July 22, 2014