inoperable hepatocellular carcinoma
Conditions
Interventions
Group 1: carbon ion stereotactic radiotherapy
Group 2: microwave ablation
Sponsors
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Technical or functional irresectable primary or recurrent HCC • = 3 hepatic HCC-lesions, each of =3 cm diameter • Informed consent • ECOG 0-2 • CILD PUGH A-B7 (in case of liver cirrhosis) • BCLC 0-B • Age = 18 years
Exclusion criteria
Exclusion criteria: • Previous radiotherapy or local ablation of the HCC-lesion of interest • Planned liver transplantation at the time of inclusion • Patient is not able to consent • Microwave Ablation is technically not feasible (e.g. central localisation of the HCC lesion) • Carbon ion radiation is technically not feasible • Active medical implants for which there is no authorization for ion irradiation at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...) • Simultaneous participation in another clinical study that could influence the outcome of this study or the other study • CHILD-PUGH > B7 (in case of liver cirrhosis) • BCLC > B • ECOG > 2 • Extrahepatic HCC disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority of the experimental group, carbon ion stereotactic radiotherapy, as compared to the control group, microwave ablation, with respect to the primary endpoint (local tumor control after 24 months) will be evaluated using a logistic regression model which adjusts for center, tumor size and number of lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Course of tumor marker (in case of AFP-elevation at start of treatment) • Toxicity (incl. liver function and changes in MELD score) • Overall survival (OS) • Progression-free survival (PFS) • Local Progression-free survival (LPFS) • Quality of life (EORTC QLQ-C30, FACT_Hep, EQ-5D) • Comfort of therapy (Patient-reported Outcome measurements) • Morphologic and functional changes in imaging after treatment • Analysis of radiation and ablation procedures as well as of the performed imaging | — |
Countries
Germany
Contacts
Public ContactJakob Liermann
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Outcome results
None listed