search
Back to results

Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma (ASTrH)

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TACE
SBRT
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCC (diagnosis: histological or radiological)
  • Age: 18-80
  • Number of lesions 1-3 lesions
  • Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
  • Sufficient non-tumorous liver volume (≥ 800 cm3)
  • Child Pugh Score: A5-6 or B7
  • BCLC A or B
  • Patient is illegible or refused surgical resection or orthotopic liver transplant
  • Blood work (within 2 weeks before registration):
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)
  • Platelets ≥50,000 cells/mm³
  • AST (and ALT) < 5 times ULN
  • Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

  • Evidence of extrahepatic disease (lymph node or distant metastases)
  • Evidence of macroscopic vascular invasion
  • Evidence of an arterio-portal or arterio-venous fistulas
  • History of previous malignancy
  • Active hepatitis B
  • Previous SIRT
  • Previous Sorafenib in the last 8 weeks
  • Pregnant and lactating females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TACE+SBRT.

    Arm Description

    If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .

    Outcomes

    Primary Outcome Measures

    1-year local control rate
    After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)

    Secondary Outcome Measures

    Qualtiy of life based on EORTC QLQC30
    alive subjects will fill quality of life questionnaires (EORTC QLQC30) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.
    1- year progression free survival
    After one year from the end of the treatment, the percentage of alive subjects without the apperance of new hepatic and/or extra-heaptic new lesions outside the SBRT-field. This will be measured using contrast-enhanced CT scan Liver/Abdomen and Thorax
    Quality of life based on EORTC QLQ-HCC18
    alive subjects will fill quality of life questionnaires (EORTC QLQ-HCC18) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.

    Full Information

    First Posted
    July 2, 2021
    Last Updated
    August 6, 2021
    Sponsor
    RWTH Aachen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04996914
    Brief Title
    Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
    Acronym
    ASTrH
    Official Title
    Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RWTH Aachen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection or orthotopic liver transplant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma Non-resectable

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TACE+SBRT.
    Arm Type
    Experimental
    Arm Description
    If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .
    Intervention Type
    Procedure
    Intervention Name(s)
    TACE
    Intervention Description
    1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.
    Intervention Type
    Radiation
    Intervention Name(s)
    SBRT
    Intervention Description
    SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged. Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) BED (α/β 10Gy) 5x 10 Gy @ 83% isodose = 50 Gy (100 Gy) 8 x 7.5 Gy @ 83% isodose = 60 Gy (105 Gy)
    Primary Outcome Measure Information:
    Title
    1-year local control rate
    Description
    After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)
    Time Frame
    12 Months
    Secondary Outcome Measure Information:
    Title
    Qualtiy of life based on EORTC QLQC30
    Description
    alive subjects will fill quality of life questionnaires (EORTC QLQC30) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.
    Time Frame
    12 Months
    Title
    1- year progression free survival
    Description
    After one year from the end of the treatment, the percentage of alive subjects without the apperance of new hepatic and/or extra-heaptic new lesions outside the SBRT-field. This will be measured using contrast-enhanced CT scan Liver/Abdomen and Thorax
    Time Frame
    12 Months
    Title
    Quality of life based on EORTC QLQ-HCC18
    Description
    alive subjects will fill quality of life questionnaires (EORTC QLQ-HCC18) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HCC (diagnosis: histological or radiological) Age: 18-80 Number of lesions 1-3 lesions Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm Sufficient non-tumorous liver volume (≥ 800 cm3) Child Pugh Score: A5-6 or B7 BCLC A or B Patient is illegible or refused surgical resection or orthotopic liver transplant Blood work (within 2 weeks before registration): Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³) Platelets ≥50,000 cells/mm³ AST (and ALT) < 5 times ULN Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min Exclusion Criteria: Evidence of extrahepatic disease (lymph node or distant metastases) Evidence of macroscopic vascular invasion Evidence of an arterio-portal or arterio-venous fistulas History of previous malignancy Active hepatitis B Previous SIRT Previous Sorafenib in the last 8 weeks Pregnant and lactating females
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Allam Mohamed, MBBS,MSc, MD
    Phone
    8036866
    Ext
    +49-241
    Email
    amohamed@ukaachen.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J. Eble, Professor Dr. med.
    Organizational Affiliation
    University medical center RWTH Aachen
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Philipp Bruners, Professor Dr. med.
    Organizational Affiliation
    University medical center RWTH Aachen
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ahmed Allam Mohamed, MBBS, MSc, MD
    Organizational Affiliation
    University medical center RWTH Aachen
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma

    We'll reach out to this number within 24 hrs