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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

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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
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  More Information

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



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