This phase II trial studies how well cisplatin and radiation therapy after surgery work in treating patients with stage I-III human papillomavirus (HPV)-related oropharyngeal squamous cell cancer. Drugs used in chemotherapy, such as cisplatin, 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 cisplatin and radiation therapy after surgery may work better in treating patients with stage I-III HPV-related oropharyngeal squamous cell cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03621696.
PRIMARY OBJECTIVE:
I. To determine the percent weight loss in patients during post-operative adjuvant modified chemoradiation therapy (POAmCRT) (Arm 1) starting at day 1 and ending on the last day of radiation therapy (RT).
SECONDARY OBJECTIVES:
I. To evaluate the proportion of percutaneous endoscopic gastrostomy (PEG) tube placements in each arm.
II. To determine the serum creatinine changes in patients receiving POAmCRT (Arm 1).
III. To evaluate the narcotics administration of patients 6 weeks after POAmCRT (Arm 1).
IV. To determine the disease recurrence rate at 24 months post-treatment in each arm.
V. To determine progression free survival (PFS) and overall survival (OS) for each arm.
EXPLORATORY OBJECTIVE:
I. To document the measures of quality of life (QOL) at baseline, during treatment, and through one year after completion of treatment in each arm.
OUTLINE: Patients are assigned to 1 of 3 arms.
ARM I: Patients undergo surgical resection per standard of care. Patients who are intermediate risk receive a single dose of cisplatin intravenously (IV) over 60 minutes. Patients also undergo radiation therapy over 21 fractions 5 days a week for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients who are low risk undergo surgical resection per standard of care and radiation therapy as in Arm I in the absence of disease progression or unacceptable toxicity.
ARM III: Patients who are high risk undergo surgical resection per standard of care and radiation therapy over 30 fractions 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with extracapsular extension or positive margins also receive cisplatin IV over 60 minutes on days 1, 22, and 36.
After completion of study treatment, patients are followed up at 6 weeks, 4, 6, 12, 18, 24, 30, 36, 48, and 60 months.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorDouglas Ray Adkins
