Recruiting NCT04996914
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TACE, SBRT.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma Non-resectable. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
Interventions
- 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) 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)
Primary outcome measures
- 1-year local control rate [Time frame: 12 Months]
Secondary outcome measures (5)
- 1- year progression free survival [Time frame: 12 Months]
- Qualtiy of life based on EORTC QLQC30 [Time frame: 12 Months]
- Quality of life based on EORTC QLQ-HCC18 [Time frame: 12 Months]
- Possibility of a secondary resection/organ transplant [Time frame: 3 Years]
- Side effects [Time frame: 6 months]
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 B7-8
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- RWTH Aachen University Hospital — Aachen
Identifiers
NCT: NCT04996914 · 20-341