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

Titre officiel

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

Sommaire:

L’objectif de cette étude de phase II à répartition aléatoire est de comparer formellement la radiothérapie à la chirurgie transorale comme traitement principal du carcinome oropharyngé à un stade précoce chez des patients négatifs pour le VPH.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov

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