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

Official Title

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


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

Trial Description

Primary Outcome:

  • Disease-Specific Survival
Secondary Outcome:
  • Overall Survival
  • Progression-Free Survival
  • Local-Regional Failure
  • Distant Failure
  • Any Failure
  • Quality of Life
  • Quality of Life
  • Quality of Life
  • Quality of Life
  • Quality of Life
  • Quality of Life
  • Toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
  • Feeding tube rate at 1 year
  • CTCAE Dysphagia Grade
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.

View this trial on

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.


Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society