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

February 9, 2017 updated by: University of Florida

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx

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

Study Overview

Status

Terminated

Conditions

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

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated at radiaton oncology clinic

Description

Inclusion Criteria:

* Nasopharynx cancer.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Photon/Proton Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collect and analyze morbidity outcomes
Time Frame: After radiation therapy, every 4 months for at least 10 years
After radiation therapy, every 4 months for at least 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Collect and analyze tumor control outcomes
Time Frame: 12 months and 24 months after radiation therapy then annually for 10 years
12 months and 24 months after radiation therapy then annually for 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 0605-NP01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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