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


N/A
18 Years
N/A
Open (Enrolling)
Both
Oropharyngeal Cancers

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Trial Information

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


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.

Exclusion Criteria:

- Evidence of distant metastasis.

- Previous irradiation for head and neck cancer.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Collect and analyze morbidity outcomes: incidence of xerostomia

Outcome Time Frame:

Periodically until final analysis

Safety Issue:

Yes

Principal Investigator

Robert S Malyapa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0601-OP01

NCT ID:

NCT00797446

Start Date:

September 2007

Completion Date:

November 2056

Related Keywords:

  • Oropharyngeal Cancers
  • Oropharyngeal
  • cancer
  • proton
  • radiation
  • outcomes
  • Oropharyngeal Neoplasms

Name

Location
University of Florida Proton Therapy Institute Jacksonville, Florida  32206