NCT04920344

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-19
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2021-06-09
• Last updated: 2023-11-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study