This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.
Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years due to the increased incidence of human papillomavirus-positive (HPV) infection and \* malignancy within the oropharynx. The prevailing treatment philosophy within head and neck oncology is that deintensifying treatment could still provide equivalent oncologic outcomes, while further lowering toxicity profiles and improving functional outcomes to minimize the morbidity incurred by patients. The next frontier in the treatment of HPV+ OPSCC, then, is the potential use of ctHPVDNA in the treatment personalization. Patients could be stratified into risk categories based on their ctHPVDNA levels, and in turn, receive a tailored treatment intensity accordingly. The goal of this research study is to see if de-intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment when using your ctHPVDNA test results as a guide for your treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment.
If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray.
If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation.
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
RECRUITINGIndiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGDisease Free Survival
Time from surgery to first disease recurrence or death from any cause
Time frame: Up to 24 months post initial surgery
Local-reginal Control
Number of subjects with no recurrence at primary oropharyngeal site or in the neck nodal basins
Time frame: Up to 24 months post initial surgery
Overall Survival
Time from surgery to death from any cause
Time frame: Up to 24 months post initial surgery
Distant metastasis rates
Assessed by tissue diagnosis or radiographically of recurrent disease at sites away from the primary tumor and neck nodal basins
Time frame: Up to 24 months post initial surgery
Adverse Events
Number of subjects that experience adverse events, grades 1-5, as assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0
Time frame: up to 6 months post initial surgery
Swallowing-related Quality Of Life
Assessed using MD Anderson Dysphagia Inventory (MDADI)
Time frame: 3 months, 6 months, 12 months, and 24 months post initial surgery
Gastrostomy tube dependence rates
Assessed by confirmation of feeding tube in-situ in subject and being utilized for nutrition
Time frame: 12 and 24 months post intial surgery
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