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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

Tracking Information
First Submitted Date November 24, 2008
First Posted Date November 25, 2008
Last Update Posted Date February 10, 2017
Study Start Date June 2008
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2013)
Collect and analyze morbidity outcomes [ Time Frame: After radiation therapy, every 4 months for at least 10 years ]
Original Primary Outcome Measures
 (submitted: November 24, 2008)
Collect and analyze morbidity outcomes: • Incidence of Xerostomia [ Time Frame: Every 4 months until final analysis ]
Change History Complete list of historical versions of study NCT00797290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2013)
Collect and analyze tumor control outcomes [ Time Frame: 12 months and 24 months after radiation therapy then annually for 10 years ]
Original Secondary Outcome Measures
 (submitted: November 24, 2008)
Collect and analyze tumor control outcomes [ Time Frame: When each patient has been followed for a minimum of 12 months and again at 24 months. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx
Official Title A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx
Brief Summary The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated at radiaton oncology clinic
Condition Nasopharynx Cancer
Intervention Not Provided
Study Groups/Cohorts Photon/Proton Radiation Therapy
Photon/Proton Radiation Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 29, 2015)
9
Original Estimated Enrollment
 (submitted: November 24, 2008)
100
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

* Nasopharynx cancer.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Previous radiation for head and neck cancer.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00797290
Other Study ID Numbers UFPTI 0605-NP01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
PRS Account University of Florida
Verification Date February 2017