OncoMatch/Clinical Trials/NCT04681417
Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
Is NCT04681417 recruiting? Yes, currently enrolling (May 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
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).
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.
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