Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

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Brief Title

Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

Official Title

A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of Local Control in the Globe at 12 Months


Condition

Retinoblastoma

Intervention

Proton Beam Radiation Therapy

Study Arms / Comparison Groups

 Proton Beam Radiation Therapy
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

2

Start Date

January 2007

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Dan Gombos, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00432445

Organization ID

2005-0883

Secondary IDs

NCI-2012-01427

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Dan Gombos, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

February 2015