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
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Condition or disease |
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Pituitary Adenoma |
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 |

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 or 12 months and then again after 24 months to a maximum of 10 years. ]
- 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. ]

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
United States, Florida | |
University of Florida Proton Therapy Institute | |
Jacksonville, Florida, United States, 32206 |
Principal Investigator: | Ronny L Rotondo, MD, CM, FRCPC | University of Florida Proton Therapy Institute |
Publications:
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00798057 |
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 |
Pituitary tumor Outcomes Proton radiation |
Adenoma Pituitary Neoplasms Pituitary Diseases 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 |