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. 2016 Sep 28;34(3):160–167. doi: 10.3857/roj.2016.01970

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.