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Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00432445
Recruitment Status : Terminated (Low accrual.)
First Posted : February 7, 2007
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Retinoblastoma
Interventions Radiation: Proton Beam Radiation Therapy
Procedure: Ophthalmic EUA
Enrollment 2
Recruitment Details Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Study closed early due to low accrual, few eligible participants.
Arm/Group Title Proton Beam Radiation Therapy
Hide Arm/Group Description Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Proton Beam Radiation Therapy
Hide Arm/Group Description Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
No analysis performed as a result of small study population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
2
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Rate of Local Control in the Globe at 12 Months
Hide Description Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis performed. Study did not meet anticipated enrollment.
Arm/Group Title Proton Beam Radiation Therapy
Hide Arm/Group Description:
Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Data collected at time point post radiation therapy for retinoblastoma at the following intervals: 3 months (+/- 1 month), 6 months (+/- 1 month), then annually (+/- 1 month) for the first five years. Overall study period: January 2007 to February 2014.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proton Beam Radiation Therapy
Hide Arm/Group Description Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
All-Cause Mortality
Proton Beam Radiation Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Proton Beam Radiation Therapy
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Eye disorders   
Retinopathy  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Proton Beam Radiation Therapy
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Eye disorders   
Post-radiation keratopathy  1  2/2 (100.00%)  2
Retinopathy  1  2/2 (100.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dan Gombos, MD/Professor, Ophthalmology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-6920
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00432445     History of Changes
Other Study ID Numbers: 2005-0883
NCI-2012-01427 ( Registry Identifier: NCI CTRP )
First Submitted: February 5, 2007
First Posted: February 7, 2007
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015