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NCT00186888 · ClinicalTrials.gov registry record · Phase 3
Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT00186888 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 107 participants.
The verdict
NCT00186888, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
Interventions
- RADIATION External Beam Radiation
- PROCEDURE Enucleation
- DRUG Vincristine, Carboplatin
- PROCEDURE Focal Therapies
- DRUG Vincristine and Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2005-04-07 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00186888
The ClinicalTrials.gov registry entry for NCT00186888 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which External Beam Radiation is the first listed.
NCT00186888 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00186888 about?
NCT00186888 is a clinical study titled "Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma". Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and wh...
What is the current status of trial NCT00186888?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2005-04-07. Estimated completion is 2024-11-12.
What interventions are being tested in trial NCT00186888?
The interventions under investigation include: External Beam Radiation (RADIATION), Enucleation (PROCEDURE), Vincristine, Carboplatin (DRUG), Focal Therapies (PROCEDURE), Vincristine and Topotecan (DRUG).
Who is sponsoring clinical trial NCT00186888?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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