Clinical trial · Interventional
Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
NCT00432445CI-TRIAL-00016947terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ophthalmic EUA | Procedure | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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)
- interventionNames
- Radiation: Proton Beam Radiation Therapy
- Procedure: Ophthalmic EUA
Primary outcomes (1)
- measure
- Rate of Local Control in the Globe at 12 Months
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.