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Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma

Head and Neck Cancer Clinical Trial

Official title:
A Phase II Randomized Trial for HPV-Negative Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR)

Clinical Trial Summary

The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.

Clinical Trial Description

This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3)

The randomized phase II design is required for three reasons:

1. The randomization will provide an appropriate control group to serve as a comparator for the experimental arm. Historical or contemporaneous non-randomized controls would not be appropriate due to the multitude of biases that could be introduced by patient selection and other confounders.

2. A small sample size will allow for adequate power to assess for progression-free survival, and also an assessment of quality of life, overall survival and toxicity.

3. The results will allow for a decision as to whether a multi-institutional phase III trial is warranted, and inform the design of such a trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04220749
Study type Interventional
Source Lawson Health Research Institute
Contact Susan Archer
Phone 519-685-8618
Email susan.archer@lhsc.on.ca
Status Recruiting
Phase Phase 2
Start date June 25, 2020
Completion date February 2028
View Details
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