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Study Summary
No. 2005-0883:.......Eye......Dan Gombos......Ophthalmology/Head & Neck Surgery
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Study Summary Title
Study Summary
Number:		2005-0883
Study Title:A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
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Physician New Patient Referral
Name:Dan GombosPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Ophthalmology/Head & Neck SurgeryReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6920
Contact us about clinical trials
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General Information
Disease Group:EyeSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Participants should return to M.D. Anderson on a weekly to monthly basis. Data
will be collected at time point post XRT at the following intervals: 1 month, 3
months, 6 months, 1 year, 18 months, then annually for the first five years.
Treatment
Agents:		Proton Therapy
Radiation		Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.
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Study Status Information
Study Activation / Registration Date:01/18/2007
IRB Review and Approval Date:06/21/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Active or recurrent retinoblastoma patient eligible for treatment of external beam radiation therapy.

2) A parent or guardian who can provide informed consent to a minor or child participant.

3) No concurrent infection.

4) No contraindication for repeated general anesthesia/sedation.
Exclusion Criteria:1) Inability to return for multiple examinations under anesthesia

2) Medical contraindication for exams under anesthesia/sedation.

3) Unreliable follow-up.
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Links
Registration Number: NCT00432445
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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