Table 2:
Title | Phase | Interventions | Enrollment | Estimated Completion | Primary Outcome Measure(s) | NCT# | Study Sponsor |
---|---|---|---|---|---|---|---|
A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma Radiotherapy vs. Trans-Oral Surgery (ORATORIO II) | 2 | De-escalated primary CRT (60 Gy +/− cisplatin) is compared with transoral surgery, neck dissection and adjuvant RT (50–60 Gy, depending on risk) | 140 | 2028 | Overall Survival | NCT03210103 | Lawson Health Research Institute |
Quality of Life After Primary Transoral Robotic Surgery vs Intensity-modulated Radiotherapy for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma: A Randomized National Trial (QoLATI) | 2 | TORS, neck dissection +/− CRT is compared with primary CRT. | 138 | 2029 | Swallowing related quality of life (MDADI) | NCT04124198 | Christian von Buchwald |
Phase III Study Assessing The “Best of” Radiotherapy Compared to the “Best of” Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0 Oropharyngeal Carcinoma | 3 | Transoral surgery and neck dissection is compared with RT and neck dissection | 170 | 2026 | Change in MDADI scores | NCT02984410 | European Organization for Research and Treatment of Cancer (EORTC) |
Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer | 4 | Transoral surgery, neck dissection +/− CRT is compared with primary CRT | 280 | 2023 | Time to local or locoregional failure or death from any cause | NCT03691441 | Universitätsklinikum Hamburg-Eppendorf |
Data from clinicaltrials.gov; Abbreviations- RT: radiation therapy, CRT: chemoradiation therapy, Gy: Gray, MDADI:MD Anderson Dysphagia Inventory