Table 1.
Main de-escalation clinical trials ongoing evaluating cetuximab in combination with RT for HPV-related OPSCC.
| Strategy | Country | Trial | Phase | N | HPV diagnosis technic | Primary objective | Comments |
|---|---|---|---|---|---|---|---|
| Cetuximab with IMRT radiation (in comparison with IMRT-cisplatin) |
US | RTOG 1016 NCT01302834 |
Phase III | 987 | p16INK4a IHC | OS (non-inferiority) | Cisplatin day 1 and 22 |
| Australia | TROG 1201 NCT01855451 |
Phase III | 189 | p16INK4a IHC | Symptom severity | Weekly cisplatin Evaluate smoking history |
|
| UK | De-ESCALaTE NCT01874171 |
Phase III | 334 | p16INK4a IHC | Overall severe (acute and late) toxicity (Grade 3–5) | Cisplatin day 1, 22, and 43 Bulky disease with >10 p/y smoking history excluded |