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Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial.


ABSTRACT: BACKGROUND:Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. METHODS:This is a multicenter phase II study randomizing one hundred and forty patients with T1-2?N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60?Gy)?±?concomitant chemotherapy and TOS?±?de-escalated adjuvant radiotherapy (50-60?Gy based on risk factors). Patients will be stratified based on smoking status (

SUBMITTER: Nichols AC 

PROVIDER: S-EPMC7023689 | BioStudies | 2020-01-01

SECONDARY ACCESSION(S): 10.15585/mmwr.mm6526a1

REPOSITORIES: biostudies

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