Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 19, 2021

Primary Completion Date

May 8, 2025

Study Completion Date

May 8, 2025

Conditions
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma
Interventions
PROCEDURE

Transoral Surgery

Patients will undergo transoral surgery

RADIATION

External Beam Radiation Therapy

Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.

DRUG

Cisplatin

Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.

PROCEDURE

Incisional Tumor Biopsy

Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

DIAGNOSTIC_TEST

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."

Trial Locations (3)

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Brunswick

07103

Rutgers Cancer Institute of New Jersey at University Hospital, Newark

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Rutgers, The State University of New Jersey

OTHER