- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02736786
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors
August 23, 2021 updated by: Samir Patel, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Oropharyngeal cancer resected using transoral surgery with positive lymphadenopathy requiring adjuvant radiation therapy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery
Time Frame: 24 months
|
Local control rate will be assessed by standard of care head and neck clinical examination during routine followup visits
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
August 23, 2021
Study Completion (Actual)
August 23, 2021
Study Registration Dates
First Submitted
April 8, 2016
First Submitted That Met QC Criteria
April 8, 2016
First Posted (Estimate)
April 13, 2016
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-000040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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