Table 1.
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.