NCT03210103

Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR II)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 The study will compare overall survival rates relative to historical controls for de-intensified primary radiotherapy \[60 GY +/- chemotherapy\] versus transoral surgery (TOS) and neck dissection \[+/- adjuvant 50Gy radiotherapy\] in patients with early T-stage HPV-positive squamous cell carcinoma of the oropharynx and to compare quality of life (QOL) profiles. The study will require a sample size of 140 patients randomized in a 1:1 ratio between the two arms. Arm 1 (radiotherapy +/1 chemotherapy) and Arm 2 (TOS) Patients will be followed for a total of 5 years

Conditions

• Oropharyngeal Cancer

Interventions

Type	Name	Description
RADIATION	Radiation	Standard of Care: Radiation +/- Chemotherapy
PROCEDURE	Transoral Surgery (TOS) + Neck Dissection	Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)

Timeline

• Start date: 2018-01-26
• Primary completion: 2028-08-15
• Completion: 2028-08-15
• First posted: 2017-07-06
• Last updated: 2026-01-28

Locations

9 sites across 2 countries: Australia, Canada