This phase II trial studies how well intensity-modulated radiation therapy (IMRT) and chemotherapy work in treating patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma. Drugs used in chemotherapy, such as cisplatin, cetuximab, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy delivers thin beams of radiation of different intensities aimed at the tumor from many angles and may reduce the damage to healthy tissue near the tumor. Giving IMRT with chemotherapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02281955.
PRIMARY OBJECTIVE:
I. To evaluate 2 year progression free survival (PFS) after de-intensified chemoradiotherapy (CRT) in HPV-positive and/or p16 positive favorable-risk oropharyngeal squamous cell carcinoma (OPSCC).
SECONDARY OBJECTIVES:
I. To assess the 2 year clinical outcomes of local control (LC), regional control (RC), local-regional control (LRC), distant metastasis free survival (DMFS), and overall survival (OS).
II. To compare head and neck quality of life assessments before, during, and after CRT.
III. To compare speech and swallowing function before and after CRT.
OUTLINE:
Patients undergo IMRT five days a week for 6 weeks. Patients without T0-2 N0-1 disease and =< 10 pack years smoking history also receive either cisplatin intravenously (IV); cetuximab IV; carboplatin IV and paclitaxel IV; or carboplatin IV on days 1, 8, 15, 22, 29, and 36 during IMRT. Patients with positive positron emission tomography (PET)/computed tomography (CT) at 10-16 weeks may undergo biopsy and/or surgical resection of the tumor and lymph node metastases at the discretion of the surgeon.
After completion of study treatment, patients are followed up every 2-3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorBhisham Chera