NCT03210103: ORATOR2

Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

Active, enrolled NA Last updated 28 January 2026

What this trial tests

NA trial testing Radiation in Oropharyngeal Cancer in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 January 2018

Primary endpoint
15 August 2028

15 August 2028

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	26 January 2018
Primary completion	15 August 2028
Estimated completion	15 August 2028
Sites	9 locations across Canada, Australia

Drugs / interventions tested

• Radiation
• Transoral Surgery (TOS) + Neck Dissection

Conditions studied

• Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

18 and older, any sex, with Oropharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management.
   Lechner M, Liu J, Masterson L, Fenton TR. · · 2022 · cited 669× · PMID 35105976 · DOI 10.1038/s41571-022-00603-7
2. HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
   Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3
3. Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial.
   Palma DA, Prisman E, Berthelet E, Tran E, et al · · 2022 · cited 76× · PMID 35482348 · DOI 10.1001/jamaoncol.2022.0615
4. Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.
   Bigelow EO, Seiwert TY, Fakhry C. · · 2020 · cited 55× · PMID 32247987 · DOI 10.1016/j.oraloncology.2020.104652
5. Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial.
   Nichols AC, Lang P, Prisman E, Berthelet E, et al · · 2020 · cited 47× · PMID 32059705 · DOI 10.1186/s12885-020-6607-z
6. De-Escalation Strategies of (Chemo)Radiation for Head-and-Neck Squamous Cell Cancers-HPV and Beyond.
   Rühle A, Grosu AL, Nicolay NH. · · 2021 · cited 35× · PMID 34064321 · DOI 10.3390/cancers13092204
7. [HPV - A different view on Head and Neck Cancer].
   Wittekindt C, Wagner S, Sharma SJ, Würdemann N, et al · · 2018 · cited 31× · PMID 29905354 · DOI 10.1055/s-0043-121596
8. Advances in Imaging for HPV-Related Oropharyngeal Cancer: Applications to Radiation Oncology.
   Salzillo TC, Taku N, Wahid KA, McDonald BA, et al · · 2021 · cited 23× · PMID 34455992 · DOI 10.1016/j.semradonc.2021.05.001