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Proton Therapy for Chordomas and/or Chondrosarcomas (CH01)

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797602
First received: November 24, 2008
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.


Condition
Chordomas
Chondrosarcomas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Outcomes Protocol of Proton Beam Radiation Therapy for Chordomas and/or Chondrosarcomas of the Base of Skull and/or Spine

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Collect and analyze outcome data on tumor control. [ Time Frame: When each patient has been followed for a minimum of 12 month and then again after 24 months to a maximum of 10 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collect and analyze data on normal tissue morbidity. [ Time Frame: When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years. ] [ Designated as safety issue: Yes ]
    Specifically analyzing pituitary, visual and hearing function.


Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Proton Radiation

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.

  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 a radiation oncology clinic

Criteria

Inclusion Criteria:

  • Histologically proven chordoma or chondrosarcoma.
  • Sites: base of skull and/or spine.
  • Age 18 years or older.

Exclusion Criteria:

  • Previous radiation to the head and neck or brain.
  • Evidence of metastatic disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797602

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: Robert S Malyapa, MD, PhD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Robert S Malyapa, MD, PhD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Contact the University of Florida Proton Therapy Institute  This link exits the ClinicalTrials.gov site

Publications:
Dahlin DC, Unni KK: Bone tumors general aspects and data on 8542 cases, 4th edition. Springfield, IL: Charles C Thomas, 1986, pp 119 - 140.
Mendenhall WM, Mendenhall CM, Lewis SB, Villaret DB, Mendenhall NP: Skull base chordoma. Head & Neck 2005; 27: 159-165.
Fuller DB and Bloom JG: Radiotherapy for chordoma. Int J Radiat Oncol Biol Phys 1988; 15:331-339.
Hug EB, Sweeney RA, Nurre PM, Holloway KC, Slater JD, Munzenrider JE. Proton therapy in management of pediatric base of skull tumors. Int J Radiat Oncol Biol Phys 2002; 52: 1017-1024.
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: NCT00797602     History of Changes
Other Study ID Numbers: UFPTI 0607-CH01
Study First Received: November 24, 2008
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Chordomas
Chondrosarcomas
Cancer
Outcomes
Proton radiation

Additional relevant MeSH terms:
Chondrosarcoma
Chordoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on May 16, 2013