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Proton Radiation Therapy for Pituitary Adenoma (PI01)

This study has been terminated.
(Due to slow enrollment and feasibility issues.)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00798057
First received: November 24, 2008
Last updated: October 2, 2015
Last verified: October 2015
  Purpose
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
Pituitary Adenoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma

Resource links provided by NLM:


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 or 12 months and then again after 24 months to a maximum of 10 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: October 2007
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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 to 100 Years   (Adult, Senior)
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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: November 24, 2008
Last Updated: October 2, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016