A Study Of Using Proton Beam Therapy Which Spares Mucosal Tissue Following The Removal Of Oropharyngeal Tumors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000040
- Scottsdale/Phoenix, Arizona: 16-000040
NCT ID: NCT02736786
Sponsor Protocol Number: 16-000040
About this study
The purpose of this study is to evaluate the clinical outcomes of lower intensity (mucosal tissue sparing) proton beam therapy after the surgical removal of oropharyngeal tumors in cancer patients who have a favorable level of risk.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 randomization to an investigational head and neck protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Daniel Ma, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Samir Patel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available