This is a non-randomized, open-label phase II clinical trial that studies the effect of reduced dose radiation therapy and chemotherapy after surgery in treating patients with human papillomavirus (HPV) caused throat cancer. Giving reduced dose radiation therapy and chemotherapy after surgery may improve quality of life compared with standard of care primary chemoradiation approach without compromising survival.
PRIMARY OBJECTIVE: I. To measure swallowing function and disease specific quality of life of patients with oropharyngeal cancer treated with transoral surgery and reduced intensity adjuvant therapy. SECONDARY OBJECTIVES: I. To examine kinetics of circulating tumor deoxyribonucleic acid (DNA) in patients treated with transoral surgery. II. To estimate local control, progression free and overall survival using transoral surgery and reduced intensity adjuvant therapy. OUTLINE: Based on pathologic findings after standard of care transoral surgery, patients are assigned to 1 of 3 groups. GROUP I (LOW RISK): Patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation. GROUP II (MEDIUM RISK): Patients whose tumor was removed completely but has certain features that make it more likely to come back such as growth around the nerves or into the vessels, or has more than one lymph nodes involved, will undergo external body radiation therapy (EBRT) for 5 weeks in the absence of disease progression or unacceptable toxicity. GROUP III (HIGH RISK): Patients whose tumor has a "positive margin", which means the tumor could not be removed with healthy tissue around it or tumor grows significantly outside the lymph node will undergo EBRT for 6 weeks and receive cisplatin intravenously (IV) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients will undergo transoral surgery
Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
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 Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
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, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, United States
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
Time frame: At baseline.
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
Time frame: At 24 weeks post completion of therapy.
MD Anderson Dysphagia Index (MDADI)
MDADI is a 20 item quality of life instrument specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients and has been widely used and validated in this population. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
Time frame: At 1 year post completion of therapy.
Locoregional control.
Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).
Time frame: At 3 years post completion of therapy
Disease free survival.
Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).
Time frame: At 3 years post completion of therapy
Progression free survival.
Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).
Time frame: At 3 years post completion of therapy
Overall survival.
Will be assessed using survival analysis (e.g., Kaplan-Meier method and Cox proportional hazards model).
Time frame: At 3 years post completion of therapy
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. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The higher the score - the better the outcome.
Time frame: At baseline, 24 weeks and 1 year post completion of therapy
European Quality of Life Five Dimension Five Level Scale Questionnaire scores
Euro-QOL 5 dimension scale is a generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer. Euro-QOL 5 dimension scale is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: At baseline, 24 weeks, and 1 year post completion of therapy
Rate of gastrostomy tube dependence
Percentage of patients requiring a gastrostomy tube after completion of therapy will be analyzed using generalized linear model (GLM) analysis.
Time frame: At baseline, 24 weeks, and 1 year post completion of therapy
Penetration-Aspiration Score on Modified Barium Swallow examination
Objective swallowing function assessment using modified barium swallow (MBS) evaluation with aspiration-penetration scale. 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. The higher the score, the worse is the outcome.
Time frame: Baseline and 1 year post completion of therapy
Correlation of circulating tumor deoxyribonucleic acid (ctDNA) levels with known adverse pathological features
Correlation of ctDNA levels at baseline with known adverse pathological features such as, number of involved lymph nodes, extranodal extension and positive margins. Will be analyzed using GLM analysis.
Time frame: At baseline and at 4 weeks post-surgery
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