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The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE+SBRT. | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Qualtiy of life based on EORTC QLQC30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Allam Mohamed, MBBS,MSc, MD | Contact | +49241 80-8926 | amohamed@ukaachen.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael J. Eble, Professor Dr. med. | University medical center RWTH Aachen | Study Chair |
| Philipp Bruners, Professor Dr. med. | University medical center RWTH Aachen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWTH Aachen University Hospital | Recruiting | Aachen | North Rhine-Westphalia | 52074 | Germany |
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| SBRT | Radiation | 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) |
|
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 |
| 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 |
| Possibility of a secondary resection/organ transplant | Possibility of a secondary resection/organ transplant (Yes/ No) | 3 Years |
| Side effects | 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 | 6 months |
| Ahmed Allam Mohamed, MBBS, MSc, MD |
| University medical center RWTH Aachen |
| Study Chair |
| Oliver Beetz, Prof. Dr.med . MHBA | University medical center RWTH Aachen | Study Chair |
| Marie-Luise Berres, Prof. Dr.med. | University medical center RWTH Aachen | Study Chair |