Clinical trial NCT00798057: Proton Radiation Therapy for Pituitary Adenoma
Official title: Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pituitary Adenoma
Keywords: Pituitary tumor
Outcomes
Proton radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at a radiation oncology clinic

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.

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 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.

Primary outcomes:
measure: Collect and analyze outcome data on tumor control.
timeFrame: 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 outcomes:
measure: Collect and analyze outcome data on normal tissue morbidity.
timeFrame: When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Ronny L Rotondo, MD, CM, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/cncr.20412.
citation: 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. doi: 10.1093/neuonc/1.1.14.
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. doi: 10.1046/j.1365-2265.1999.00865.x.
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. doi: 10.1111/j.1365-2265.1993.tb02137.x.
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. doi: 10.1016/s0360-3016(01)01535-8.
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.
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. doi: 10.1210/jc.2004-1152. Epub 2004 Nov 23.
citation: 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. doi: 10.1016/s0167-8140(03)00117-8.
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. doi: 10.1016/s0167-8140(01)00403-0.
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. doi: 10.1007/s00066-006-1500-5.