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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Samir Patel, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02736786
First received: April 8, 2016
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
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.

Condition
Oropharyngeal Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 67
Study Start Date: March 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Oropharyngeal cancer resected using transoral surgery with positive lymphadenopathy requiring adjuvant radiation therapy.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02736786

Contacts
Contact: Manuel Vargas 480-342-1267 vargas.manuel@mayo.edu
Contact: Heather Young 480-342-1262 young.heather@mayo.edu

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Samir Patel, Assistant Professor of Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02736786     History of Changes
Other Study ID Numbers: 16-000040
Study First Received: April 8, 2016
Last Updated: June 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
proton

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on March 24, 2017