ORATOR
Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial
Phase 2N = 68NCT01590355
- Population
- T1-T2, N0-2 (4 cm or less) oropharyngeal squamous cell carcinoma, ECOG 0-2
- Design
- Investigator-initiated, multicentre, international, open-label, parallel-group phase 2 randomised study at six hospitals in Canada and Australia: 68 patients (34 per group) with T1-T2, N0-2 (4 cm or less) oropharyngeal squamous cell carcinoma were randomised 1:1, stratified by p16 status, between August 2012 and June 2017. Primary endpoint: swallowing-related quality of life at 1 year (MD Anderson Dysphagia Inventory, MDADI), powered to detect a 10-point improvement in the TORS plus neck dissection group. Analyses by intention to treat.
- Primary endpoint
- Swallowing-related quality of life (MDADI)
- Arms
- Radiotherapy (control, n = 34): Radiotherapy 70 Gy, with chemotherapy if N1-2
- TORS plus neck dissection (experimental, n = 34): Transoral robotic surgery plus neck dissection, with or without adjuvant chemoradiotherapy based on pathology
- People
- Nichols AC, London Health Sciences Centre (sponsor on ClinicalTrials.gov)
Δ Grade 2-5 adverse events+6 points
Show the numbers
| Endpoint | Analysis | TORS plus neck dissection | Radiotherapy | Effect |
|---|---|---|---|---|
| Grade 2-5 adverse eventsRandomised patients (34 per arm) | finalmedian follow-up 5.1 yearsNichols 2024 | 97% | 91% | P=0.61Percentages are 31 of 34 (radiotherapy) and 33 of 34 (TORS plus neck dissection). More neutropenia and hearing loss in the radiotherapy arm and more dysphagia and other pain in the TORS arm at grades 2-5 (all P < .05). No differences in OS or PFS (abstract gives no values). |
| Endpoint | Analysis | TORS plus neck dissection | Radiotherapy | Effect |
|---|---|---|---|---|
| Grade 2-5 adverse eventsRandomised patients (34 per arm) | finalmedian follow-up 5.1 yearsNichols 2024 | 97% | 91% | P=0.61Percentages are 31 of 34 (radiotherapy) and 33 of 34 (TORS plus neck dissection). More neutropenia and hearing loss in the radiotherapy arm and more dysphagia and other pain in the TORS arm at grades 2-5 (all P < .05). No differences in OS or PFS (abstract gives no values). |
Appears in
Sources
Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, et al. Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial. Lancet Oncol. 2019;20(10):1349-1359.
Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, et al. Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Final Results of the ORATOR Randomized Trial. J Clin Oncol. 2024;42(34):4023-4028.