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
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Condition or disease |
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Chordomas Chondrosarcomas |
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 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Group/Cohort |
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Proton Radiation |
- 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. ]
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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
United States, Florida | |
University of Florida Proton Therapy Institute | |
Jacksonville, Florida, United States, 32206 |
Principal Investigator: | Ronny L Rotondo, MD | University of Florida Proton Therapy Institute |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00797602 |
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 |
Chordomas Chondrosarcomas Cancer Outcomes Proton radiation |
Chondrosarcoma Chordoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma Neoplasms, Germ Cell and Embryonal |