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TerminatedNCT00798057PI01Updated Oct 5, 2015

Proton Radiation Therapy for Pituitary Adenoma

An observational study in Pituitary Adenoma, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-10-05.

Sponsored by University of Florida · Observational

Why this study was terminated
Due to slow enrollment and feasibility issues.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pituitary Adenoma

Keywords

  • Pituitary tumor
  • Outcomes
  • Proton radiation
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In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 16 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated at a radiation oncology clinic

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Proton Radiation
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What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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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Study locations

1 site
  • University of Florida Proton Therapy Institute
    Jacksonville, Florida 32206, United States
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References and documents

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. doi: 10.1002/cncr.20412. PubMed 15274075 ↗
  • 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. PubMed 11554386 ↗
  • 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. PubMed 10469006 ↗
  • 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. PubMed 8334743 ↗
  • 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. PubMed 11483339 ↗
  • 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. doi: 10.1210/jc.2004-1152. Epub 2004 Nov 23. PubMed 15562021 ↗
  • 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. PubMed 12885446 ↗
  • 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. PubMed 11730999 ↗
  • 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. PubMed 16826355 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00798057
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Nov 25, 2008
Start date
Oct 2007
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Oct 5, 2015

Study contacts

Ronny L Rotondo, MD, CM, FRCPC
principal investigator · University of Florida Proton Therapy Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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