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

N/ANot Yet RecruitingNCT04996914

RWTH Aachen University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma Non-resectable

Interventions

TACEPROCEDURE

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.

SBRTRADIATION

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) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 B7-8 * 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 ≥ 50 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 * Previous SIRT * Previous Sorafenib in the last 8 weeks * Pregnant and lactating females

Outcomes

Primary Outcomes

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)

Time frame: 12 Months

Secondary Outcomes

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.

Time frame: 12 Months

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

Time frame: 12 Months

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.

Time frame: 12 Months

Central Contacts

Ahmed Allam Mohamed, MBBS,MSc, MD

CONTACT

+49241 80-8926 amohamed@ukaachen.de

Data from ClinicalTrials.gov

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