Proton Radiation Therapy for Pituitary Adenoma

NCT ID: NCT00798057

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Conditions

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Pituitary Adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Proton Radiation

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronny L Rotondo, MD, CM, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

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University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8334743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11483339 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 15562021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12885446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11730999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16826355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15274075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11554386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10469006 (View on PubMed)

Other Identifiers

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UFPTI 0701-PI01

Identifier Type: -

Identifier Source: org_study_id

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