A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Completed

Conditions studied: Oropharyngeal Tumor

In brief

This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.

Key facts

Study ID

NCT02736786

Run by

Mayo Clinic

People needed

64

Starts

2016-03-01

Expected to finish

2021-08-23

Last updated by the study team

2021-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Resection of oropharyngeal tumor by transoral surgery using frozen section margin analysis resulting in a negative margin resection
• No extensive perineural invasion after review by head and neck pathologist
• No lymphovascular invasion after review by head and neck pathologist
• Pathologic stage T1-2 N1-3 M0 disease

You may not qualify if…

• T3 or T4 primary stage disease
• Prior radiation therapy to the head and neck

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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