Table 1:
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