TY - JOUR
T1 - Preservation of swallowing in resected oral cavity squamous cell carcinoma
T2 - Examining radiation volume effects (PRESERVE): Study protocol for a randomized phase II trial
AU - Lang, Pencilla
AU - Contreras, Jessika
AU - Kalman, Noah
AU - Paterson, Claire
AU - Bahig, Houda
AU - Billfalk-Kelly, Astrid
AU - Brennan, Sinead
AU - Rock, Kathy
AU - Read, Nancy
AU - Venkatesan, Varagur
AU - Sathya, Jinka
AU - Mendez, Lucas C.
AU - MacNeil, S. Danielle
AU - Nichols, Anthony C.
AU - Fung, Kevin
AU - Mendez, Adrian
AU - Winquist, Eric
AU - Kuruvilla, Sara
AU - Stewart, Paul
AU - Warner, Andrew
AU - Mitchell, Sylvia
AU - Theurer, Julie A.
AU - Palma, David A.
N1 - Publisher Copyright:
© 2020 The Author(s).
PY - 2020/8/14
Y1 - 2020/8/14
N2 - 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.
AB - 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.
KW - De-escalation
KW - Head and neck cancer
KW - Oral cavity
KW - Quality of life
KW - Radiotherapy
KW - Randomized controlled trial
KW - Recurrence
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85089531668&partnerID=8YFLogxK
U2 - 10.1186/s13014-020-01636-x
DO - 10.1186/s13014-020-01636-x
M3 - Article
C2 - 32795322
AN - SCOPUS:85089531668
SN - 1748-717X
VL - 15
JO - Radiation Oncology
JF - Radiation Oncology
IS - 1
M1 - 196
ER -