Clinical trial NCT00797602: Proton Therapy for Chordomas and/or Chondrosarcomas
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chordomas
Chondrosarcomas
Keywords: Chordomas
Chondrosarcomas
Cancer
Outcomes
Proton radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at a radiation oncology clinic

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.

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 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.

Primary outcomes:
measure: Collect and analyze outcome data on tumor control.
timeFrame: 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 outcomes:
measure: Collect and analyze data on normal tissue morbidity.
timeFrame: When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Ronny L Rotondo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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