Photon/Proton Radiation Therapy for Oropharyngeal Cancers

Terminated

• Conditions: Oropharyngeal Cancers

• Registration Number: NCT00797446
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect and analyze morbidity outcomes: incidence of xerostomia	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States