Primary Radiation Therapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

Official Title

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

Summary:

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumours treated with a primary radiation therapy 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

Trial Description

Primary Outcome:

• Overall Survival

Secondary Outcome:

• Quality of Life 1 year post treatment
• Progression free survival comparison with historical controls
• 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
• Speech intelligibility
• Normalcy of diet
• 2 year progression-free survival comparison between Arm 1 and Arm 2

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumours treated with a primary radiation therapy 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 radiation therapy [60 GY +/- chemotherapy] versus transoral surgery (TOS) and neck dissection [+/- adjuvant 50Gy radiation therapy] 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

View this trial on ClinicalTrials.gov