Proton Radiation Therapy for Pituitary Adenoma

NCT00798057 | Terminated

• 1 other identifier: UFPTI 0701-PI01
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

Pituitary tumor; Outcomes; Proton radiation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Proton Radiation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at a radiation oncology clinic

You may qualify if:

• 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

You may not qualify if:

• \*Previous radiation that would compromise the ability to deliver the prescribed treatment.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (10)

• 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.

  PMID: 15274075 BACKGROUND

• 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.

  PMID: 11554386 BACKGROUND

• 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.

  PMID: 10469006 BACKGROUND

• 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.

  PMID: 8334743 BACKGROUND

• 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.

  PMID: 11483339 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15562021 BACKGROUND

• 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.

  PMID: 12885446 BACKGROUND

• 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.

  PMID: 11730999 BACKGROUND

• 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.

  PMID: 16826355 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Ronny L Rotondo, MD, CM, FRCPC

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

US (1)