15
Participants
Start Date
July 19, 2021
Primary Completion Date
May 8, 2025
Study Completion Date
May 8, 2025
Transoral Surgery
Patients will undergo transoral surgery
External Beam Radiation Therapy
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Cisplatin
Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
Incisional Tumor Biopsy
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
MD Anderson Dysphagia Index
MDADI is a 20 item quality of life questionnaire specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
University of Washington Quality of Life Questionnaire
University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
Euro-QOL 5 dimension scale questionnaire
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
Modified barium swallow (MBS) evaluation with aspiration-penetration scale
"The videofluoroscopic modified barium swallow (MBS) study is the gold standard for for the evaluation of dysphagia, and specifically, airway protective mechanisms.~The penetration/aspiration (PEN/ASP) scale is a routinely used eight-point scale designed to describe the depth of bolus penetration into the airway and the patient response to the penetration or aspiration."
Rutgers Cancer Institute of New Jersey, New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Brunswick
Rutgers Cancer Institute of New Jersey at University Hospital, Newark
National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER