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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02736786

Enrollment

Registered

2016-04-13

Start date

2016-03-31

Completion date

2021-08-23

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Tumor

Keywords

proton

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery	24 months	Local control rate will be assessed by standard of care head and neck clinical examination during routine followup visits

Countries

United States

Outcome results