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. Author manuscript; available in PMC: 2021 Dec 1.
Published in final edited form as: Otolaryngol Clin North Am. 2020 Sep 8;53(6):981–994. doi: 10.1016/j.otc.2020.07.009

Table 1:

Adjuvant Therapy De-escalation Trials in Progress

Name Title Phase Interventions Enrollment Estimated Completion Primary Outcome Measure(s) NCT # Study Sponsor

DART-HPV DART-HPV: A Phase III Evaluation of De-escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer 3 Reduced RT (30 – 36 Gy, depending on risk group) + docetaxel is compared with 60 Gy +/− cisplatin 214 2024 Adverse Events Rate NCT02908477 Mayo Clinic
PATHOS A Phase III Trial of Risk stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus(HPV)-Positive Oropharyngeal Cancer 3 Intermediate risk group: reduced RT (50 Gy) is compared with 60 Gy; High risk group: adjuvant CRT is compared with adjuvant RT alone 1100 2026 MDADI/Overall survival co-primary endpoint NCT02215265 Lisette Nixon
MINT Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV Related Oropharynx Squamous Cell Carcinoma: “The Minimalist Trial(MINT)” 2 Low risk group: reduced RT (42 Gy) alone, intermediate risk group: reduced RT (42 Gy) one cisplatin dose, high risk group: standard of care (60 Gy + 3 doses cisplatin) 43 2022 Percent weight loss in patients during modified adjuvant CRT NCT03621696 Washington University School of Medicine

Data from clinicaltrials.gov; Abbreviations- RT: radiation therapy, CRT: chemoradiation therapy, Gy: Gray, PFS: progression-free survival, MDADI:MD Anderson Dysphagia Inventory