Table 3.
Phase 3 randomized clinical trials investigating role of radiotherapy in hepatocellular carcinoma
NCT no. | Estimated enrollment | Arms | Primary outcome measures | Secondary or other outcome measures | Estimated primary completion date |
---|---|---|---|---|---|
NCT02794337 | 386 | Arm 1: DEB TACE | In-field PFS | CSS, tumor response, QoL, toxicity | Jan 2019 |
Arm 2: DEB TACE & SBRT | |||||
NCT01963429 | 144 | Arm 1: RFA | local PFS | DFS, OS | Dec 2018 |
Arm 2: Proton beam therapy | |||||
NCT01730937 | 368 | Arm 1: Sorafenib tosylate | OS | TTP, PFS, toxicity, QoL, quality adjusted survival | Jun 2016 |
Arm 2: SBRT and sorafenib tosylate | |||||
NCT02762266 | 160 | Arm 1: TACE | FFLP | PFS, OS | - |
Arm 2: SBRT | |||||
NCT02511522 | 60 | Arm 1: Best supportive care | Improvement of pain/discomfort | Adverse event, 90-day survival, QoL, reduction of opioid use | Jul 2018 |
Arm 2: Best supportive care & RT | |||||
NCT02323360 | 80 | Arm 1: SBRT | Local control | PFS, OS, toxicity | Nov 2016 |
Arm 2: TACE | |||||
NCT02125396 | 150 | Arm 1: RT | OS | Recurrence rate | Dec 2017 |
Arm 2: TACE |
DEB, drug eluting bead; TACE, trans-arterial chemoembolization; SBRT, stereotactic body radiotherapy; PFS, progression free survival; CSS, cause specific survival; QoL, quality of life; RFA, radiofrequency ablation; DFS, disease free survival; OS, overall survival; TTP, time to progression; FFLP, freedom from local progression; RT, radiotherapy.