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Proton Therapy for Chordomas and/or Chondrosarcomas (CH01)

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: NCT00797602
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease
Chordomas Chondrosarcomas

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 : 189 participants
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
Study Start Date : January 2007
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Proton Radiation



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
    Specifically analyzing pituitary, visual and hearing function.



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 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.

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): NCT00797602


Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Ronny L Rotondo, MD University of Florida Proton Therapy Institute

Additional Information:
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.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797602     History of Changes
Other Study ID Numbers: UFPTI 0607-CH01
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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