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