A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

University of Florida1 site in 1 country10 target enrollmentSeptember 2007

ConditionsOropharyngeal Cancers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Oropharyngeal Cancers
Sponsor: University of Florida
Enrollment: 10
Locations: 1
Primary Endpoint: Collect and analyze morbidity outcomes: incidence of xerostomia
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Detailed Description

This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

July 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
•Stage-grouping:
•Stage I (T1N0)
•Stage II (T2N0)
•Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
•Unfavorable stage III and selected stage IV (any T, N2c/N3)
•Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
•Will receive treatment with proton radiation.

Exclusion Criteria

•Evidence of distant metastasis.
•Previous irradiation for head and neck cancer.

Outcomes

Primary Outcomes

Collect and analyze morbidity outcomes: incidence of xerostomia

Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes

Collect and analyze tumor control outcomes.(From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)