Hepatocellular Carcinoma Non-resectable
Conditions
Brief summary
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
Interventions
PROCEDURETACE
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.
RADIATIONSBRT
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)
Sponsors
RWTH Aachen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year local control rate | 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| 1- year progression free survival | 12 Months | 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 |
| Qualtiy of life based on EORTC QLQC30 | 12 Months | 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. |
| Quality of life based on EORTC QLQ-HCC18 | 12 Months | 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. |
| Possibility of a secondary resection/organ transplant | 3 Years | Possibility of a secondary resection/organ transplant (Yes/ No) |
| Side effects | 6 months | will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 and Child Pugh Score change till 6 months after the study |
Countries
Germany
Contacts
CONTACTAhmed Allam Mohamed, MBBS,MSc, MD
STUDY_CHAIRMichael J. Eble, Professor Dr. med.
University medical center RWTH Aachen
STUDY_CHAIRPhilipp Bruners, Professor Dr. med.
University medical center RWTH Aachen
STUDY_CHAIRAhmed Allam Mohamed, MBBS, MSc, MD
University medical center RWTH Aachen
STUDY_CHAIROliver Beetz, Prof. Dr.med . MHBA
University medical center RWTH Aachen
STUDY_CHAIRMarie-Luise Berres, Prof. Dr.med.
University medical center RWTH Aachen
Outcome results
None listed