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

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dc.contributor.authorNichols, Anthony C
dc.contributor.authorLang, Pencilla
dc.contributor.authorPrisman, Eitan
dc.contributor.authorBerthelet, Eric
dc.contributor.authorTran, Eric
dc.contributor.authorHamilton, Sarah
dc.contributor.authorWu, Jonn
dc.contributor.authorFung, Kevin
dc.contributor.authorde Almeida, John R
dc.contributor.authorBayley, Andrew
dc.contributor.authorGoldstein, David P
dc.contributor.authorEskander, Antoine
dc.contributor.authorHusain, Zain
dc.contributor.authorBahig, Houda
dc.contributor.authorChristopoulous, Apostolos
dc.contributor.authorHier, Michael
dc.contributor.authorSultanem, Khalil
dc.contributor.authorRichardson, Keith
dc.contributor.authorMlynarek, Alex
dc.contributor.authorKrishnan, Suren
dc.contributor.authorLe, Hien
dc.contributor.authorYoo, John
dc.contributor.authorMacNeil, S. D
dc.contributor.authorMendez, Adrian
dc.contributor.authorWinquist, Eric
dc.contributor.authorRead, Nancy
dc.contributor.authorVenkatesan, Varagur
dc.contributor.authorKuruvilla, Sara
dc.contributor.authorWarner, Andrew
dc.contributor.authorMitchell, Sylvia
dc.contributor.authorCorsten, Martin
dc.contributor.authorRajaraman, Murali
dc.contributor.authorJohnson-Obaseki, Stephanie
dc.contributor.authorEapen, Libni
dc.contributor.authorOdell, Michael
dc.contributor.authorChandarana, Shamir
dc.contributor.authorBanerjee, Robyn
dc.contributor.authorDort, Joseph
dc.contributor.authorMatthews, T. W
dc.contributor.authorHart, Robert
dc.contributor.authorKerr, Paul
dc.contributor.authorDowthwaite, Samuel
dc.contributor.authorGupta, Michael
dc.contributor.authorZhang, Han
dc.contributor.authorWright, Jim
dc.contributor.authorParker, Christina
dc.contributor.authorWehrli, Bret
dc.contributor.authorKwan, Keith
dc.contributor.authorTheurer, Julie
dc.contributor.authorPalma, David A
dc.date.accessioned2020-02-16T01:02:35Z
dc.date.available2020-02-16T01:02:35Z
dc.date.issued2020-02-14
dc.date.updated2020-02-16T01:02:35Z
dc.description.abstractAbstract 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 (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. Discussion This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.
dc.identifier.citationBMC Cancer. 2020 Feb 14;20(1):125
dc.identifier.doihttps://doi.org/10.1186/s12885-020-6607-z
dc.identifier.urihttp://hdl.handle.net/1880/111650
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.titleTreatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial
dc.typeJournal Article
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