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Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant

Primary Purpose

Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
stereotactic body radiation therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCC is staged as Barcelona B or C (non-resectable and non-transplantable)
  • Treatment with SBRT can occur within 6 weeks of staging laparoscopy
  • Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC
  • Patients with clinical/imaging features of HCC but without biopsy confirmation can be initially enrolled on the protocol and undergo staging laparoscopy for biopsy confirmation with the option of having the fiducials placed in the same procedure; but if the histology is not confirmed and/or other exclusion criteria is met patient will be taken off protocol
  • Total aggregate of maximal dimension of liver tumors =< 8 cm
  • Cirrhotic patients Child Pugh Class A or B
  • Patient should be medically eligible for liver transplantation
  • Absolute neutrophil count > 1,500/ul
  • Platelets > 50,000 ul (after transfusion if required)
  • Hemoglobin greater than 10.0 g/dL
  • Total bilirubin < 2.0 mg/dL
  • AST(SGOT)/ALT(SGPT) < 2 X institutional upper limit of normal
  • Life expectancy > 12 weeks
  • ECOG performance status < 2 or Karnofsky >= 70%
  • Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
  • Women must not be pregnant or nursing
  • Sexually active men and women must agree to use accepted forms of birth control
  • Provision of informed consent: Patient must be able to provide verbal and written informed consent

Exclusion Criteria:

  • Patient with previous history of abdominal radiation
  • Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Evidence of metastatic disease prior to staging laparoscopy
  • Evidence of main Portal Vein thrombosis
  • History of cardiac ischemia or stroke within last 6 months
  • Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm I

    Arm Description

    Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy

    Secondary Outcome Measures

    Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0
    Rate of local progression as assessed by RECIST criteria
    Number of patients who achieve liver transplantation
    Survival rate

    Full Information

    First Posted
    September 1, 2010
    Last Updated
    April 17, 2012
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01194206
    Brief Title
    Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant
    Official Title
    Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study being rewritten
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.
    Detailed Description
    PRIMARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 months.SECONDARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 and 6 months.II. To determine the rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors. III. To determine the rate of local progression after SBRT. (Based onRECIST criteria)IV. To determine the number of patients who achieve liver transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy delivered within 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Radiation
    Intervention Name(s)
    stereotactic body radiation therapy
    Other Intervention Name(s)
    SBRT, stereotactic radiation therapy, stereotactic radiotherapy
    Intervention Description
    At least 3 gold standard Cyberknife fiducials will be placed in the liver w/in 6 cm of the tumor for image guidance during radiation therapy. At least 1 wk will elapse between fiducial placement and tx planning simulation to allow for fiducial settling and any migration.The full radiation tx will be given ideally in 3 consecutive days. In any case there must be a minimum of 24 hrs between fractions and all 3 fractions will be delivered w/in 14 days. The dose to at least 95% of the tumor will be 37.5 Gy total in 12.5 Gy fractions.
    Primary Outcome Measure Information:
    Title
    Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy
    Time Frame
    At 3 months
    Secondary Outcome Measure Information:
    Title
    Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0
    Time Frame
    Baseline, at 1 month, 3 months and 6 months
    Title
    Rate of local progression as assessed by RECIST criteria
    Time Frame
    Baseline, at 1 month, 3 months and 6 months
    Title
    Number of patients who achieve liver transplantation
    Time Frame
    at 6 months after SBRT
    Title
    Survival rate
    Time Frame
    Survival will be measured from the first day of treatment on study until death of any cause.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HCC is staged as Barcelona B or C (non-resectable and non-transplantable) Treatment with SBRT can occur within 6 weeks of staging laparoscopy Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC Patients with clinical/imaging features of HCC but without biopsy confirmation can be initially enrolled on the protocol and undergo staging laparoscopy for biopsy confirmation with the option of having the fiducials placed in the same procedure; but if the histology is not confirmed and/or other exclusion criteria is met patient will be taken off protocol Total aggregate of maximal dimension of liver tumors =< 8 cm Cirrhotic patients Child Pugh Class A or B Patient should be medically eligible for liver transplantation Absolute neutrophil count > 1,500/ul Platelets > 50,000 ul (after transfusion if required) Hemoglobin greater than 10.0 g/dL Total bilirubin < 2.0 mg/dL AST(SGOT)/ALT(SGPT) < 2 X institutional upper limit of normal Life expectancy > 12 weeks ECOG performance status < 2 or Karnofsky >= 70% Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment Women must not be pregnant or nursing Sexually active men and women must agree to use accepted forms of birth control Provision of informed consent: Patient must be able to provide verbal and written informed consent Exclusion Criteria: Patient with previous history of abdominal radiation Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years Evidence of metastatic disease prior to staging laparoscopy Evidence of main Portal Vein thrombosis History of cardiac ischemia or stroke within last 6 months Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Sanabria
    Organizational Affiliation
    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant

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