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

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:
NCT00797290
First received: November 24, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Nasopharynx Cancer
Other: Data Consolidation and Analysis

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes [ Time Frame: 12 months and 24 months after radiation therapy then annually for 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: June 2008
Estimated Study Completion Date: October 2056
Estimated Primary Completion Date: October 2056 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Photon/Proton Radiation Therapy
Photon/Proton Radiation Therapy
Other: Data Consolidation and Analysis

  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 treated at radiaton oncology clinic

Criteria

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 ClinicalTrials.gov identifier: NCT00797290

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:
Sanguineti G, Geara FB, Garden AS, et al.: Carcinoma of the nasopharynx treated by radiotherapy alone: Determinants of local and regional control. Int J Radiat Oncol Biol Phys 37: 985-96, 1997.
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.
Vikram B, Mishra UB, Strong EW, et al. Patterns of failure in carcinoma of the nasopharynx: I. Failure at the primary site. Int J Radiat Oncol Biol Phys. 11:1455- 1459, 1985.
Xia P, Fu KK, Wong GW, et al. Comparison of treatment plans involving intensity modulated radiotherapy for nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 48; 329-337, 2000.
Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation retinopathy after megavoltage external-beam irradiation: Analysis of time-dose factors. Int. J. Radiat. Oncol. Biol. Phys. 30: 765-773, 1994.
Bhandare N, Monroe AT, Morris CG, Bhatti TM, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 62: 1070-1077, 2005.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797290     History of Changes
Other Study ID Numbers: UFPTI 0605-NP01
Study First Received: November 24, 2008
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014