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

Hepatocellular Carcinoma Non-resectable Clinical Trial

— ASTrH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04996914
• Other study ID #: 20-341
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2021
• Source: RWTH Aachen University
• Contact: Ahmed Allam Mohamed, MBBS,MSc, MD
• Phone: 8036866
• Email: amohamed[@]ukaachen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

Procedure:
• TACE
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.

Radiation:
• SBRT
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 (a/ß 10Gy) 5x 10 Gy @ 83% isodose = 50 Gy (100 Gy) 8 x 7.5 Gy @ 83% isodose = 60 Gy (105 Gy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 Months
Secondary	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.	12 Months
Secondary	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	12 Months
Secondary	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.	12 Months