A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/20/2018 |
| Start Date: | March 2016 |
| End Date: | March 2020 |
| Contact: | Anne Bosworth |
| Email: | bosworth.anne@mayo.edu |
| Phone: | 480-342-1267 |
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.
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.
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
Exclusion Criteria:
- T3 or T4 primary stage disease
- Prior radiation therapy to the head and neck
We found this trial at
2
sites
Click here to add this to my saved trials
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
Click here to add this to my saved trials