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Early-stage squamous cell carcinoma of the oropharynx : radiotherapy vs. trans-oral robotic surgery ( ORATOR ) -- study protocol for a randomized phase II trial . BACKGROUND The incidence of oropharyngeal squamous cell carcinoma ( OPSCC ) has markedly increased over the last three decades due to newly found associations with human papillomavirus ( HPV ) infection . Primary radiotherapy ( RT ) is the treatment of choice for OPSCC at most centers , and over the last decade , the addition of concurrent chemotherapy has led to a significant improvement in survival , but at the cost of increased acute and late toxicity . Transoral robotic surgery ( TORS ) has emerged as a promising alternative treatment , with preliminary case series demonstrating encouraging oncologic , functional , and quality of life ( QOL ) outcomes . However , comparisons of TORS and RT in a non-randomized fashion are susceptible to bias . The goal of this randomized phase II study is to compare QOL , functional outcomes , toxicity profiles , and survival following primary RT ( ± chemotherapy ) vs. TORS ( ± adjuvant [ chemo ] RT ) in patients with OPSCC . METHODS/DESIGN The target patient population comprises OPSCC patients who would be unlikely to require chemotherapy post-resection : Tumor stage T1-T2 with likely negative margins at surgery ; Nodal stage N0-2 , ≤3 cm in size , with no evidence of extranodal extension on imaging . Participants will be randomized in a 1:1 ratio between Arm 1 ( RT ± chemotherapy ) and Arm 2 ( TORS ± adjuvant [ chemo ] RT ) . In Arm 1 , patients with N0 disease will receive RT alone , whereas N1-2 patients will receive concurrent chemoradiation . In Arm 2 , patients will undergo TORS along with selective neck dissections , which may be staged . Pathologic high-risk features will be used to determine the requirement for adjuvant radiotherapy +/- chemotherapy . The primary endpoint is QOL score using the M.D . Anderson Dysphagia Inventory ( MDADI ) , with secondary endpoints including survival , toxicity , other QOL outcomes , and swallowing function . A sample of 68 patients is required . DISCUSSION This study , if successful , will provide a much-needed randomized comparison of the conventional strategy of primary RT vs. the novel strategy of primary TORS . The trial is designed to provide a definitive QOL comparison between the two arms , and to inform the design of an eventual phase III trial for survival outcomes . TRIAL REGISTRATION NCT01590355 .
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Intervention_Physical
radiotherapy vs.
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Intervention_Surgical
trans-oral robotic surgery ( ORATOR ) -- study
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Intervention_Physical
Primary radiotherapy ( RT )
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Intervention_Physical
concurrent chemotherapy
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Intervention_Surgical
Transoral robotic surgery ( TORS )
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Intervention_Surgical
TORS
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Intervention_Physical
RT
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Outcome_Physical
QOL
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Outcome_Other
functional outcomes
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Outcome_Adverse-effects
toxicity profiles
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Outcome_Mortality
survival
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Participant_Condition
squamous cell carcinoma
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Participant_Condition
OPSCC