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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Oropharyngeal Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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