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)

Summary:

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 ClinicalTrials.gov