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OpenTrials
Completed

NCT Number: NCT02736786

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

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.

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Key information

Conditions

Oropharyngeal Tumor Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for 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 radiation therapy to the head and neck

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2016
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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