Proton Radiation Therapy for Pituitary Adenoma - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00798057

Purpose

You are being asked to take part in this study because you have pituitary adenoma and are going to receive radiation therapy.

The purpose of this study is to collect and analyze the information pertaining to the tumor response and side effects from treatment.

Our hypothesis is that with the more localized radiation therapy technique such as protons, we can maintain a high tumor control, improve tumor response and decrease radiation related toxicity. The results of these effects should translate into improved quality of life for our patients.

Condition	Intervention
Pituitary Adenoma	Radiation: Proton Radiation Therapy

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma

Further study details as provided by University of Florida:

Primary Outcome Measures:

Collect and analyze outcome data on tumor control: Radiological response and Endocrine/Symptom response [ Time Frame: When each patient has been followed for a minimum or 12 months and then again after 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Collect and analyze outcome data on normal tissue morbidity and compare IMRT vs. proton treatment plans. [ Time Frame: Every 4 months until the final analysis. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2057
Estimated Primary Completion Date:	July 2057 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Proton Radiation Therapy: Experimental	Radiation: Proton Radiation Therapy Proton Radiation Therapy - 45 CGE at 1.8 CGE in 25 fractions

Detailed Description:

Radiation is typically given daily Monday-Friday. Each proton treatment takes approximately 30-60 minutes. Each IMRT photon treatment (if needed) will take 20-30 minutes. IMRT (Intensity Modulated Radiation Therapy) is another technique that may be used to give radiation.

STRATIFY/RECORD

Hormonal status:

Functional (GH, ATCH, prolactin) vs. non-functional adenoma

Gender:

Male vs. female

Surgery:

Gross total resection as their initial surgery (for recurrent pts) vs. subtotal resection vs. biopsy

Recurrent vs. primary tumor size:

less than 4cm vs. greater than or equal to 4 cm

Treatment:

PROTONS

GOAL = CTV dose = 45 CGE

@ 1.8 CGE in 25 fractions (CGE = Proton dose x 1.1)

Up to 30% of total dose may be delivered by photons using IMRT if necessary

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven pituitary adenoma.
Currently measurable disease greater than 3cm in diameter or less than 3mm from the optic chiasm on post-operative radiological examination (MRI or CT in ≤ 2mm contiguous slices with contrast, unless medically contraindicated).
Age 18 years or older.
Zubrod performance status 0-2 within 4 weeks per Appendix I.
Must have signed study-specific informed consent.
Completed all required studies per section 4.0.
Life expectancy > 2 years, despite pituitary disease.
Status post biopsy, gross total resection (from initial surgery for recurrent disease) or subtotal resection.
Neurological function status <4 per Appendix III.

Exclusion Criteria:

Previous radiation that would compromise the ability to deliver the prescribed treatment.
Major medical illness, addiction or psychiatric impairments which, in the investigator's opinion, will prevent the consent process, completion of the protocol therapy and/or follow-up compliance.
Pregnant or breastfeeding women, or women and men of childbearing potential not willing to use contraception during treatment and for at least 3 months thereafter.
Malignancy within the past 5 years, unless non-melanomatous skin cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798057

Contacts

Contact: Amanda D Prince, RN	(904) 588-1298	aprince@floridaproton.org
Contact: Cindy L Carroll	(904) 588-1288	ccarroll@floridaproton.org

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Amanda D Prince, RN 904-588-1298 aprince@floridaproton.org
Contact: Cindy L Carroll (904) 588-1288 ccarroll@floridaproton.org
Principal Investigator: Felicia E Snead, MD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Felicia E Snead, MD

University of Florida Proton Therapy Institute

More Information

Responsible Party:	University of Florida Proton Therapy Institute ( Felicia E. Snead, MD )
Study ID Numbers:	UFPTI 0701-PI01
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00798057
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Pituitary

Study placed in the following topic categories:

Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Pituitary Neoplasms
Central Nervous System Neoplasms
Brain Diseases

Supratentorial Neoplasms
Brain Neoplasms
Endocrinopathy
Adenoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Hypothalamic Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009