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: June 19, 2014
Last verified: June 2014

February 5, 2007
June 19, 2014
January 2007
February 2014   (final data collection date for primary outcome measure)
Rate of Local Control in the Globe at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00432445 on ClinicalTrials.gov Archive Site
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Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma

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.

External photon beam radiation therapy (which is current standard of care) has been used in the treatment of retinoblastoma. It is a form of radiation therapy in which the radiation is delivered by a machine pointed at the area to be radiated.

Proton beam radiation therapy is a form of external photon beam radiation therapy, but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor, which helps preserve other tissues and cause fewer side effects.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your eye doctor will perform an assessment of your eye, including an exam while you are under anesthesia. This exam will include a dilated eye exam, photography of your affected eye (by a Ret-Cam), ultrasound of your affected eye, and imaging scans, such as computed tomography (CT) or magnetic resonance imaging (MRI), if the doctor thinks it is necessary. The assessments will be done to check and confirm the status of the disease.

After diagnosis of retinoblastoma, the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you. If external photon beam radiotherapy is deemed appropriate for you, you will be eligible to receive proton beam radiation therapy in this study.

If you are found to be eligible to take part in this study, you will be treated with proton beam radiation therapy. Treatment will begin within 1 week of referral to the M. D. Anderson Proton Center. It will be given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.

Within 2-4 weeks after completion of therapy, you will have an eye exam performed under anesthesia (like the one during screening). You will have repeated eye exams under anesthesia, depending on the appearance and response of the tumor to therapy. This will occur about every 1-4 months.

You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse.

If the disease gets worse or you experience any intolerable side effects, you may be taken off treatment.

You will be required to have lifelong eye and medical assessments to continue to monitor you for disease. If no disease is found 5 years after completion of proton beam radiation therapy, you will be considered free of disease. You will then have annual (yearly) eye and pediatric assessment through adulthood.

This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinoblastoma
  • Radiation: Proton Beam Radiation Therapy
    Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.
  • Procedure: Ophthalmic EUA
    Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)
    Other Names:
    • eye exam
    • ophthalmic exam
Experimental: Proton Beam Radiation Therapy
Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take 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)
Interventions:
  • Radiation: Proton Beam Radiation Therapy
  • Procedure: Ophthalmic EUA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432445
2005-0883, NCI-2012-01427
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Dan Gombos, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP