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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: April 8, 2016
Date Started: March 2016
Date Completion: March 2020
Last Updated: June 7, 2016
Last Verified: June 2016