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. 2022 Sep 27;14(19):4694. doi: 10.3390/cancers14194694

Table 1.

Comparison of different imidazole-based compound in clinical trials done in patients with HNSCC.

Compound NCT Identifier
(Ongoing Studies)
Clinical Trial Study Design Per Dose Route of
Administration
Other Treatment
Modalities
Study
Assessment
Outcome of
the Study
Reference
Metronidazole - Oral cavity epidermal Carcinoma Pilot study 6 g/m2 Orally Interstitial irradiation Radiosensitization 69% had complete local regression [29]
Etanidazole - HNSCC; Randomized Phase II 2 g/m2 Orally Radiotherapy Radiosensitization No difference in LRC and OS [30]
Etanidazole - Locally advanced HNSCC Randomized phase III (RTOG 85-27) 2 g/m2 Orally Radiotherapy Radiosensitization No difference in LRC and OS [31]
Misonidazole - Locally advanced HNSCC Randomized Phase III (EORTC 22811) 1 g/m2 Orally Radiotherapy (3 times per day) Radiosensitization No difference in LRC and OS [32]
Misonidazole - Larynx/pharynx carcinoma Randomized Phase III (DAHANCA 2) 11 g/m2 Orally Radiotherapy (split course) Radiosensitization Improved LRC in pharyx but not overall group [33]
Misonidazole - Unresectable HNSCC Randomized Phase 1/II (RTOG 79-04) 1.5 g/m2 Orally Radiotherapy Radiosensitization No significant difference in LRC [34]
Nimorazole - Larynx/Pharynx carcinoma Randomized Phase III (DAHANCA 5-85) 1.2 g/m2 Orally Radiotherapy Radiosensitization Significant improvement in LRC [35]
Nimorazole - Unresectable HNSCC Single arm Phase II 12 g/m2,
0.9 g/m2
0.6 g/m2
Orally Radiotherapy (CHART) Radiosensitization LRC better than historical control [36]
Nimorazole - Unresected HNSCC Prospective observation 1.2 g/m2
1 g/m2
Orally Radiotherapy (HART) Radiosensitization LRC similar to historical control of chemoRT [37]
Nimorazole NCT01950689 HNSCC Randomized Phase III (NIMRAD) 1.2 g/m2 Orally Radiotherapy Radiosensitiz ation Ongoing -
Nimorazole NCT01880359 HNSCC Randomized Phase III 1.2 g/m2 Orally Radiotherapy
+ cisplatin chemo
Safety, hypoxia radiosensitization Ongoing -

LRC: locoregional control; OS: overall survival; chemoRT: chemoradiation; CHART: continuous hyperfractionated accelerated radiotherapy; HART: hyperfractionated accelerated radiotherapy.