Photon/Proton Radiation Therapy for Oropharyngeal Cancers (OP01)

This study has been terminated.
(Slow enrollment, feasibility issues)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797446
First received: November 24, 2008
Last updated: July 31, 2015
Last verified: July 2015
  Purpose

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.


Condition
Oropharyngeal Cancers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes. [ 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 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2007
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Photon/Proton Radiation Therapy
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the Radiation Oncology Clinic

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797446

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797446     History of Changes
Other Study ID Numbers: UFPTI 0601-OP01
Study First Received: November 24, 2008
Last Updated: July 31, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Oropharyngeal
cancer
proton
radiation
outcomes

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 03, 2015