Photon/Proton Radiation Therapy for Oropharyngeal Cancers (OP01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797446
First received: November 24, 2008
Last updated: March 11, 2014
Last verified: March 2014
  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: Periodically until final analysis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes. [ Time Frame: When each patient has been followed for a minimum of 12 months and then again after 24 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: September 2007
Estimated Study Completion Date: November 2056
Estimated Primary Completion Date: November 2056 (Final data collection date for primary outcome measure)
Groups/Cohorts
Photon/Proton Radiation Therapy

  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

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Roi Dagan, MD,MS         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Parsons, J.T., Mendenhall, W.M., Stringer, S.P., Amdur, R.J., Hinerman, R.W., Villaret, D.B., Moore-Higgs, G.J., Greene, B.D., Speer, T.W., Cassisi, N.J., Million, R.R.: Squamous cell carcinoma of the oropharynx: Surgery, radiation therapy, or both. Cancer. 2002; 94: 2967-80
Cooper, J.S., Fu, K., Marks, J., Silverman, S.: Late effects of radiation therapy in the head and neck region. Int J Radiat Biol Oncol Phys 1995; 31: 1141-1164.

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: March 11, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 23, 2014