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Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx (NP01)

This study has been terminated.
(Slow enrollment, Feasibility issues)
Information provided by (Responsible Party):
University of Florida Identifier:
First received: November 24, 2008
Last updated: February 9, 2017
Last verified: February 2017
The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

Nasopharynx Cancer

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

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Collect and analyze morbidity outcomes [ Time Frame: After radiation therapy, every 4 months for at least 10 years ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes [ Time Frame: 12 months and 24 months after radiation therapy then annually for 10 years ]

Enrollment: 9
Study Start Date: June 2008
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Photon/Proton Radiation Therapy
Photon/Proton Radiation Therapy

Detailed Description:
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated at radiaton oncology clinic

Inclusion Criteria:

* Nasopharynx cancer.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Previous radiation 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 identifier: NCT00797290

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

Additional Information:
Mendenhall WM, Riggs CE Jr, Cassisi NJ: Treatment of head and neck cancers. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds.: Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins, 2005., pp 662-732.
Laramore GE, ed.: Radiation Therapy of Head and Neck Cancer. Berlin: Springer-Verlag, 1989.
Cummings CW, Fredrickson JM, Harker LA, et al.: Otolaryngology - Head and Neck Surgery. Saint Louis, Mo: Mosby-Year Book, Inc., 1998.

Responsible Party: University of Florida Identifier: NCT00797290     History of Changes
Other Study ID Numbers: UFPTI 0605-NP01
Study First Received: November 24, 2008
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Nasopharynx Cancer, Proton Radiation, Outcomes

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases processed this record on April 28, 2017