Clinical trial · Observational
Proton Radiation Therapy for Pituitary Adenoma
Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma
NCT00798057CI-TRIAL-00019336PI01terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to slow enrollment and feasibility issues.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Proton Radiation
Primary outcomes (1)
- 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 (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDEzzat 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
- BACKGROUNDSurawicz 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
- BACKGROUNDTurner 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
- BACKGROUNDBrada 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
- BACKGROUNDMilker-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
- BACKGROUNDStieber 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.
- BACKGROUNDMinniti 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.