Skip to main content
. 2020 Dec;8(23):1601. doi: 10.21037/atm-20-2984

Table 1. Active clinical trials for de-escalated treatment strategies (clinicaltrials.gov).

Strategy Clinical trial number Target population Intervention/treatment Primary outcomes
Cetuximab in place of cisplatin NCT01663259 (3) 7th edition stage III-IV disease (excluding N3 or T4), smoking history <10 pack years Cetuximab given in place of cisplatin during concurrent CRT Recurrence rate at 3 years
Immunotherapy in place of cisplatin NCT03799445 (4) 8th edition stage 1 and 2 (T1 N2, T2 N1-N2, T3 N0-N2) excluding T1N0-N1 and T2N0 Single arm study of IMRT with nivolumab and ipilimumab in place of cisplatin Dose limiting toxicity, complete response rate at 6 months, progression free survival at 2 years
Radiation therapy dose reduction and/or omission of adjuvant chemotherapy NCT03323463 (5) AJCC 8th edition T1-2/N1-2b Patients receive reduced dose RT (30 Gy) over 2 weeks during concurrent CRT Treatment effectiveness at 2 years
NCT02254278 (NRG HN002 trial) (6) AJCC 7th edition T1-T2, N1-N2b or T3, N0-N2b Patients randomized to receive 60 Gy RT with or without weekly cisplatin Dysphagia severity, 2-year progression free survival
NCT03952585 (7) AJCC 8th edition T1-2, N1, M0 or T3, N0-N1, M0 Patients randomized to receive standard CRT, reduced dose RT with cisplatin, or reduced dose RT with nivolumab 2-year progression free survival and quality of life (MDADI)
Induction chemotherapy followed by reduced radiation or chemoradiation NCT04012502 (8) AJCC 8th edition T1-2/N1-3 (except T1N1M0 and single LN <3 cm) or T3-4N0-3M0 in China Patients with good response to induction chemotherapy undergo reduced dose adjuvant RT (60 Gy) and omit concurrent cisplatin 2-year progression free and overall survival
Surgery followed by reduced adjuvant therapy NCT02215265 (PATHOS Trial) (9) AJCC TNM 7th edition stage T1-T3, N0-N2b Transoral laser resection of tumors followed by reduced dose adjuvant RT Overall survival, MD Anderson Dysphagia Inventory (MDADI) score at 2 years
NCT02908477 (DART-HPV Trial) (10) Patients who have undergone transoral resection and have T3/T4 primary disease, ENE, LVI, PNI, or N2b disease or below Transoral resection followed by standard CRT or reduced dose RT with concurrent chemotherapy Treatment toxicity, overall survival, quality of life
NCT01898494 (ECOG 3311 Trial) (11) AJCC 7th T1-T2 OPSCC and N1-N2b neck disease Transoral resection of tumor and neck dissection followed by risk-adjusted adjuvant treatment 2-year progression free survival
NCT03729518 (12) AJCC 7th pathologic T0-3 and N0-N2b disease with <5 positive lymph nodes Reduced dose (50 Gy) RT with sparing of primary tumor bed in appropriate patients 2-year locoregional control
NCT01687413 (ADEPT Trial) (13) Patients that have undergone transoral resection and neck dissection with negative margins at primary site, ECS in nodal metastasis must be present Reduced dose adjuvant RT and removal of chemotherapy 5-year disease free survival and locoregional control
NCT03396718 (DELPHI Trial) (14) Patients who underwent surgical resection HPV+ OPSCC Intermediate risk patients will be treated with reduced dose RT to tumor and neck 2-year locoregional recurrence