Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

This study has been terminated.
(Low accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00432445
First received: February 5, 2007
Last updated: February 12, 2015
Last verified: February 2015
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Retinoblastoma
Interventions: Radiation: Proton Beam Radiation Therapy
Procedure: Ophthalmic EUA

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study closed early due to low accrual, few eligible participants.

Reporting Groups
  Description
Proton Beam Radiation Therapy 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).

Participant Flow:   Overall Study
    Proton Beam Radiation Therapy  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No analysis performed as a result of small study population.

Reporting Groups
  Description
Proton Beam Radiation Therapy 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).

Baseline Measures
    Proton Beam Radiation Therapy  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     2  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures

1.  Primary:   Rate of Local Control in the Globe at 12 Months   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dan Gombos, MD/Professor, Ophthalmology
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-6920
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00432445     History of Changes
Other Study ID Numbers: 2005-0883, NCI-2012-01427
Study First Received: February 5, 2007
Results First Received: February 12, 2015
Last Updated: February 12, 2015
Health Authority: United States: Institutional Review Board