OncoMatch/Clinical Trials/NCT04681417
Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
Is NCT04681417 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments for retinoblastoma.
Treatment: Melphalan or Melphalan + Topotecan · etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy · Carboplatin administered on Day 1 · Thermotherapy (local treatment) · Cryotherapy (local treatment) · Iodine-125 plaques (local treatment) · Intravitreal Melphalan chemotherapy injections (local treatment) — This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Disease stage
Required: Stage GROUP A, GROUP B, GROUP C, GROUP D, GROUP E (International Intraocular Retinoblastoma Classification)
Excluded: Stage GROUP E WITH INVASION OF THE ANTERIOR SEGMENT, GROUP E WITH MASSIVE TUMOR OF MORE THAN 2/3 OF THE EYE
Unilateral Retinoblastoma classified as group B, C (if vitreous seeds < 3 mm), D or E with no invasion of the anterior segment, and without massive tumor of more than 2/3 of the eye, eligible for conservative management, or Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one eye group D or E without invasion of the anterior segment or massive tumor of more than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment only (without IAC).
Demographics
Prior therapy
Cannot have received: chemotherapy
Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
Cannot have received: radiotherapy
Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04681417 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage GROUP A or GROUP B or GROUP C or GROUP D or GROUP E is required.
Is there an age limit?
Yes. Patients must be 6 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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