Proton Radiation Therapy for Pituitary Adenoma (PI01)

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by University of Florida

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00798057

First received: November 24, 2008

Last updated: February 27, 2015

Last verified: February 2015

History of Changes

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:

Genetics Home Reference related topics: familial isolated pituitary adenoma

MedlinePlus related topics: Pituitary Tumors

U.S. FDA Resources

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 ]


Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2051
Estimated Primary Completion Date:	October 2041 (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 and older
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

Contacts


Contact: Intake Coordinator	877-686-6009

Locations


United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator 877-686-6009
Principal Investigator: Ronny L Rotondo, MD, CM, FRCPC

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:

Contact the University of Florida Proton Therapy Institute This link exits the ClinicalTrials.gov site

Publications:

Ezzat S, Asa SL, Couldwell WT, Barr CE, Dodge WE, Vance ML, McCutcheon IE. The prevalence of pituitary adenomas: a systematic review. Cancer. 2004 Aug 1;101(3):613-9. Review.

Surawicz TS, McCarthy BJ, Kupelian V, Jukich PJ, Bruner JM, Davis FG. Descriptive epidemiology of primary brain and CNS tumors: results from the Central Brain Tumor Registry of the United States, 1990-1994. Neuro Oncol. 1999 Jan;1(1):14-25.

Turner HE, Stratton IM, Byrne JV, Adams CB, Wass JA. Audit of selected patients with nonfunctioning pituitary adenomas treated without irradiation - a follow-up study. Clin Endocrinol (Oxf). 1999 Sep;51(3):281-4.

Brada M, Rajan B, Traish D, Ashley S, Holmes-Sellors PJ, Nussey S, Uttley D. The long-term efficacy of conservative surgery and radiotherapy in the control of pituitary adenomas. Clin Endocrinol (Oxf). 1993 Jun;38(6):571-8.

Milker-Zabel S, Debus J, Thilmann C, Schlegel W, Wannenmacher M. Fractionated stereotactically guided radiotherapy and radiosurgery in the treatment of functional and nonfunctional adenomas of the pituitary gland. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1279-86.

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.

Minniti G, Traish D, Ashley S, Gonsalves A, Brada M. Risk of second brain tumor after conservative surgery and radiotherapy for pituitary adenoma: update after an additional 10 years. J Clin Endocrinol Metab. 2005 Feb;90(2):800-4. Epub 2004 Nov 23.

Bolsi A, Fogliata A, Cozzi L. Radiotherapy of small intracranial tumours with different advanced techniques using photon and proton beams: a treatment planning study. Radiother Oncol. 2003 Jul;68(1):1-14.

Cozzi L, Fogliata A, Lomax A, Bolsi A. A treatment planning comparison of 3D conformal therapy, intensity modulated photon therapy and proton therapy for treatment of advanced head and neck tumours. Radiother Oncol. 2001 Dec;61(3):287-97.

Cozzi L, Clivio A, Vanetti E, Nicolini G, Fogliata A. Comparative planning study for proton radiotherapy of benign brain tumors. Strahlenther Onkol. 2006 Jul;182(7):376-81.


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:	February 27, 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 Neoplasms Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases	Hypothalamic Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Supratentorial Neoplasms

ClinicalTrials.gov processed this record on March 01, 2015

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