This phase II trial studies how well chemotherapy and intensity-modulated radiation therapy work in treating patients with human papilloma virus (HPV)-associated oropharyngeal squamous cell cancer. 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving a lower dose of chemotherapy and radiation therapy may provide a similar cure rate as the longer, more intensive standard regimen.
Additional locations may be listed on ClinicalTrials.gov for NCT03077243.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) with > 10 pack years smoking history.
SECONDARY OBJECTIVES:
I. To prospectively assess if the changes in plasma circulating free HPV deoxyribonucleic acid (DNA) during and after treatment are associated with clinical outcomes in patients with HPV-associated OPSCC.
II. 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).
OUTLINE:
Patients receive intensity-modulated radiation therapy (IMRT) daily over 6 weeks for a total of 30 fractions. Patients (except those with T0-2 N0-1 disease and =< 10 pack years smoking history) also receive chemotherapy intravenously (IV) comprising of either cisplatin, cetuximab, carboplatin and paclitaxel, or carboplatin alone during IMRT on days 1, 8, 15, 22, 29, and 36. Patients with > 10 pack years smoking history and p53 gene mutation receive 1 additional fraction of IMRT and 1 additional dose chemotherapy.
After completion of study treatment, patients are followed up at 10-16 weeks, every 2-3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorWendell Gray Yarbrough