Clinical trial NCT00797446: Photon/Proton Radiation Therapy for Oropharyngeal Cancers
Official title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Oropharyngeal Cancers
Keywords: Oropharyngeal
cancer
proton
radiation
outcomes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Radiation Oncology Clinic

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.

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.

Primary outcomes:
measure: Collect and analyze morbidity outcomes: incidence of xerostomia
timeFrame: 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:
measure: Collect and analyze tumor control outcomes.
timeFrame: 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
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Roi Dagan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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