This study evaluates the effects of reduced radiation dose on human papillomavirus (HPV) positive squamous cell carcinoma of the oropharynx. Based on previous studies, “de-escalated” radiation has become accepted treatment, and it is thought that the reduced radiation doses will lead to improved quality of life while maintaining cure rates. This study is designed to keep track of patients who are opting for de- escalated radiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05600842.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Active
Contact: Eric Chen
Phone: 714-456-8000
PRIMARY OBJECTIVE:
I. To evaluate using an observational design, the 2-year progression-free survival of a cohort of patients treated with de-escalated radiation for human papillomavirus (HPV)-positive carcinoma of the oropharynx.
SECONDARY OBJECTIVES:
I. Overall survival.
II. Local-regional control.
OUTLINE: This is an observational study.
Patients receive standard of care (SOC) de-escalated intensity-modulated radiation therapy (IMRT) over approximately 5 weeks for a total of 30 sessions. Patients with high-risk disease (stage III and/or with > 10 pack-year tobacco history) also receive paclitaxel and carboplatin. Treatment with paclitaxel and carboplatin repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. All patients also undergo a positron emission tomography (PET) scan during screening. All patients also have the option to undergo a dental evaluation, a speech and swallow evaluation, and/or a nutritional evaluation during screening.
After completion of study, patients are followed up at 2-3 weeks, 30 days, every 6 months for 2 years, and then yearly.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorEric Chen
