NDLI: Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial

Content Provider	Springer Nature : BioMed Central
Author	Lang, Pencilla Contreras, Jessika Kalman, Noah Paterson, Claire Bahig, Houda Billfalk-Kelly, Astrid Brennan, Sinead Rock, Kathy Read, Nancy Venkatesan, Varagur Sathya, Jinka Mendez, Lucas C. MacNeil, S. Danielle Nichols, Anthony C. Fung, Kevin Mendez, Adrian Winquist, Eric Kuruvilla, Sara Stewart, Paul Warner, Andrew Mitchell, Sylvia Theurer, Julie A. Palma, David A.
Abstract	Background Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck. Methods This is a multicentre phase II study randomizing 90 patients with T1–4 N0–2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. Discussion This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials. Trial registration Clinicaltrials.gov identifier: NCT03997643 . Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020.
Related Links	https://ro-journal.biomedcentral.com/counter/pdf/10.1186/s13014-020-01636-x.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
DOI	10.1186/s13014-020-01636-x
Journal	Radiation Oncology
Issue Number	1
Volume Number	15
Language	English
Publisher	BioMed Central
Publisher Date	2020-08-14
Access Restriction	Open
Subject Keyword	Cancer Research Oncology Radiotherapy Imaging Radiology Head and neck cancer Oral cavity Recurrence Survival Quality of life Randomized controlled trial De-escalation
Content Type	Text
Resource Type	Article
Subject	Radiology, Nuclear Medicine and Imaging Oncology
Journal Impact Factor	3.3/2023
5-Year Journal Impact Factor	3.6/2023

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