Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial
| Autor: | Adrian Mendez, Andrew Warner, Eric Winquist, Varagur Venkatesan, Jinka Sathya, Astrid Billfalk-Kelly, Houda Bahig, Noah Kalman, Sara Kuruvilla, Kathy Rock, Sinead Brennan, Sylvia Mitchell, S. Danielle MacNeil, David A. Palma, Paul Stewart, Julie A. Theurer, Nancy Read, Lucas C. Mendez, Kevin Fung, Claire Paterson, J. Contreras, Pencilla Lang, Anthony C. Nichols |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Survival medicine.medical_treatment Salvage therapy Study Protocol 0302 clinical medicine Quality of life Recurrence Clinical endpoint Multicenter Studies as Topic Medicine Head and neck cancer Randomized Controlled Trials as Topic Aged 80 and over Radiotherapy Dosage Middle Aged Prognosis lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Combined Modality Therapy Dysphagia De-escalation Survival Rate Oropharyngeal Neoplasms Oncology Chemotherapy Adjuvant Randomized controlled trial 030220 oncology & carcinogenesis Neck Dissection Female Radiology medicine.symptom Odynophagia Adult lcsh:Medical physics. Medical radiology. Nuclear medicine Canada medicine.medical_specialty Adolescent lcsh:R895-920 lcsh:RC254-282 Young Adult 03 medical and health sciences Clinical Trials Phase II as Topic Humans Radiology Nuclear Medicine and imaging Oral Cavity Squamous Cell Carcinoma Aged Radiotherapy Squamous Cell Carcinoma of Head and Neck business.industry medicine.disease Oral cavity Radiation therapy Neoplasm Recurrence Local Deglutition Disorders business |
| Zdroj: | Radiation Oncology, Vol 15, Iss 1, Pp 1-12 (2020) Radiation Oncology (London, England) |
| ISSN: | 1748-717X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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