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Proton Radiation Therapy for Pituitary Adenoma (PI01)

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ClinicalTrials.gov Identifier: NCT00798057
Recruitment Status : Terminated (Due to slow enrollment and feasibility issues.)
First Posted : November 25, 2008
Last Update Posted : October 5, 2015
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 pituitary tumors and analyze possible side effects.

Condition or disease
Pituitary Adenoma

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 : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma
Study Start Date : October 2007
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 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 or 12 months and then again after 24 months to a maximum of 10 years. ]

Secondary Outcome Measures :
  1. Collect and analyze outcome 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (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 pituitary adenoma.
  • Age 18 years or older.
  • Status post biopsy, gross total resection (from initial surgery for recurrent disease) or subtotal resection.
  • Good to moderate neurological function status

Exclusion Criteria:

*Previous radiation that would compromise the ability to deliver the prescribed treatment.


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): NCT00798057


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, CM, FRCPC University of Florida Proton Therapy Institute

Additional Information:
Publications:
Stieber V, Deguzman A, et al. Pituitary. In: Perez CA, Brady LW, Halperin EC, Schmidt-Ullrich RK, editors. Principles and practice of radiation oncology. Philadelphia: Lippincott Williams and Wilkins; 2004. p.839-859.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00798057     History of Changes
Other Study ID Numbers: UFPTI 0701-PI01
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Keywords provided by University of Florida:
Pituitary tumor
Outcomes
Proton radiation

Additional relevant MeSH terms:
Adenoma
Pituitary Diseases
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms