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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797290
Recruitment Status : Terminated (Slow enrollment, Feasibility issues)
First Posted : November 25, 2008
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

Condition or disease
Nasopharynx Cancer

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.

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx
Study Start Date : June 2008
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Photon/Proton Radiation Therapy
Photon/Proton Radiation Therapy



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

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


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

* Nasopharynx cancer.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Previous radiation for head and neck cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797290


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

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00797290     History of Changes
Other Study ID Numbers: UFPTI 0605-NP01
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases