Table 2.
Current trials examining radiotherapy de-escalation for treatment of HPV-associated OPSCC.
| Trial, Accrual Dates | Trial Design (Sample Size) | Overall Stage | De-escalation Strategy | Primary Endpoint | ||
|---|---|---|---|---|---|---|
| Radiotherapy | Surgery | Systemic Therapy | ||||
| De-escalation Strategy: Radiotherapy Alone | ||||||
| NCT03777384 (13), 2018-2023 | Prospective, Observational, Phase I (n=60) | Stage I-II (AJCC 8th ed.) | De-escalated RT (not stated) | N/A | N/A | Local control, DFS |
| ReACT (NCT04900623) (14), 2021-2030 | Phase II (n=145) | Stage I-III (AJCC 8th ed.) | RT 70 Gy/35 vs de-escalated dose (not stated) +/- chemotherapy | N/A | N/A | 2-year PFS |
| NCT03215719 (15), 2017-2021 | Phase II (n=54) | Stage III-IVa (AJCC 7th ed.) | CRT 70 Gy/35 vs de-escalated dose (not stated) | N/A | N/A | 2-year PFS |
| NCT04667585 (16), 2020-2027 | Interventional (n=120) | Stage I-III (AJCC 8th ed.) | CRT 70 Gy/35 vs de-escalated dose based on mid treatment response in lymph node volume. | N/A | N/A | 2-year PFS |
| HYHOPE (NCT04580446) (17), 2020-2024 | Phase I (n=24) | Stage I-II (AJCC 8th ed.) | *CRT 46.6 Gy/15 vs CRT 52 Gy/20, reduction in elective nodal volume size | N/A | N/A | Toxicity |
| ENID (NCT04444869) (19), 2020-2024 | Phase II (n=28) | Stage I-II (AJCC 8th ed.) | *Reduced RT dose to elective nodal volume | N/A | N/A | Rate of PEG tube placement. |
| NCT03323463 (20), 2017-2022 | Phase II (n=300) | Stage III-IVa (AJCC 7th ed.) | CRT 70 Gy/35 vs CRT 30 Gy/15 | N/A | N/A | N/A |
| NCT04178174 (21), 2019-2025 | Randomized Phase II (n=106) | Stage I-II (AJCC 8th ed.) | *CRT 70 Gy/35 vs CRT 40 Gy/20 + SBRT 14 Gy/2 boost | N/A | N/A | 2-year LRC |
| NCT03799445 (22), 2019-2022 | Phase II (n=180) | Stage I-II (AJCC 8th ed.) | Ipilimumab + nivolumab + RT 60 Gy/30 | N/A | N/A | 2-year PFS, toxcitiy, 6-month complete response rate |
| NCT03396718 (23), 2018-2026 | Phase I (n=384) | Stage II-III (AJCC 8th ed.) | PO(C)RT 60-66 Gy vs PO(C)RT 48.8-55 Gy | N/A | N/A | 24-month LRC |
PORT, post-operative radiotherapy; TOS, trans-oral surgery (with neck dissection); POCRT, post-operative chemoradiotherapy; OS, overall survival; MDADI, MD Anderson dysphasia inventory; PFS, progression free survival; RT, radiotherapy; DFS, disease free survival; Fx, fraction; TORS, trans-oral robotic surgery (with neck dissection); SBRT, stereotactic body radiotherapy. *Trial with RT volume reduction.
N/A, Not applicable.