Proton Radiation Therapy for Pituitary Adenoma

Pituitary Adenoma Clinical Trial

— PI01  

Official title:

Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00798057
• Other study ID #: UFPTI 0701-PI01
• Status: Terminated
• Phase: N/A
• First received: November 24, 2008
• Last updated: October 2, 2015
• Start date: October 2007
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and analyze outcome data on tumor control.		When each patient has been followed for a minimum or 12 months and then again after 24 months to a maximum of 10 years.	No
Secondary	Collect and analyze outcome data on normal tissue morbidity.		When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.	Yes

External Links

•   Contact the University of Florida Proton Therapy Institute