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Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer (TACE-SBRT)

Primary Purpose

Carcinoma, Hepatocellular

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transarterial Chemoembolization (TACE)
TACE+Stereotactic Body Radiotherapy
Sponsored by
Juan Sanabria, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Radiotherapy, Chemoembolization

Eligibility Criteria

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

Inclusion Criteria:

  • Hepatocellular carcinoma (Barcelona Stage B or C)
  • Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
  • Age ≥ 18 years and ≤ 70 years
  • Eastern Cooperative Oncology Group Performance status ≤ 2
  • Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
  • Hemoglobin > 10.0 g/dL
  • Total bilirubin > 3.0 mg/dL
  • AST (SGOT) ≤ 3x institutional upper limit of normal
  • ALT (SGPT) ≤ 3x institutional upper limit of normal
  • Absolute neutrophil count ≥ 1,500/μl
  • Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
  • Aggregate maximal dimension of liver tumors ≤ 8 cm
  • Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
  • Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
  • Life expectancy ≥ 12 weeks
  • Ability to understand study and provide legally effective written informed consent
  • Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child
  • Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization

Exclusion Criteria:

  • History of abdominal radiation
  • Cirrhosis classified as Child Pugh Class B with score ≥ 8
  • 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 registration
  • Evidence of main portal vein thrombosis
  • History of cardiac ischemia or stroke within 6 months prior to enrollment
  • Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
  • History of sorafenib therapy within 21 days prior to enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Transarterial Chemoembolization (TACE)

    TACE+Stereotactic Body Radiotherapy

    Arm Description

    Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.

    Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.

    Outcomes

    Primary Outcome Measures

    Tumor response rate
    Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months

    Secondary Outcome Measures

    Tumor down staging
    Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months
    Frequency of adverse events
    Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors
    Incidence of local tumor progression
    Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)
    Number of patients eligibility for liver transplantation
    Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.

    Full Information

    First Posted
    November 26, 2014
    Last Updated
    November 25, 2015
    Sponsor
    Juan Sanabria, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02304445
    Brief Title
    Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer
    Acronym
    TACE-SBRT
    Official Title
    Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Necessary equipment could not be obtained.
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    November 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Juan Sanabria, MD

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Hepatocellular
    Keywords
    Radiotherapy, Chemoembolization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transarterial Chemoembolization (TACE)
    Arm Type
    Active Comparator
    Arm Description
    Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.
    Arm Title
    TACE+Stereotactic Body Radiotherapy
    Arm Type
    Experimental
    Arm Description
    Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.
    Intervention Type
    Procedure
    Intervention Name(s)
    Transarterial Chemoembolization (TACE)
    Intervention Description
    TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
    Intervention Type
    Radiation
    Intervention Name(s)
    TACE+Stereotactic Body Radiotherapy
    Intervention Description
    This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.
    Primary Outcome Measure Information:
    Title
    Tumor response rate
    Description
    Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Tumor down staging
    Description
    Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months
    Time Frame
    3 and 6 months
    Title
    Frequency of adverse events
    Description
    Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors
    Time Frame
    6 months
    Title
    Incidence of local tumor progression
    Description
    Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)
    Time Frame
    6 months
    Title
    Number of patients eligibility for liver transplantation
    Description
    Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Overall survival
    Description
    Determination of the number of subjects alive at 3 years following their final study treatment.
    Time Frame
    3 years

    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: Hepatocellular carcinoma (Barcelona Stage B or C) Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment Age ≥ 18 years and ≤ 70 years Eastern Cooperative Oncology Group Performance status ≤ 2 Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board Hemoglobin > 10.0 g/dL Total bilirubin > 3.0 mg/dL AST (SGOT) ≤ 3x institutional upper limit of normal ALT (SGPT) ≤ 3x institutional upper limit of normal Absolute neutrophil count ≥ 1,500/μl Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated) Aggregate maximal dimension of liver tumors ≤ 8 cm Cirrhosis classified as Child Pugh Class A or B (score ≤ 7) Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment Life expectancy ≥ 12 weeks Ability to understand study and provide legally effective written informed consent Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization Exclusion Criteria: History of abdominal radiation Cirrhosis classified as Child Pugh Class B with score ≥ 8 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 registration Evidence of main portal vein thrombosis History of cardiac ischemia or stroke within 6 months prior to enrollment Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation History of sorafenib therapy within 21 days prior to enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Sanabria, MD
    Organizational Affiliation
    Midwestern Reginal Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

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