drugset / Trial / NCT04681417

Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

NCT04681417

Phase 2/3 Recruiting 225 enrolled Institut Curie Fondation Rothschild Paris · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-03-25
Primary completion
2035-01-20
Completion
2036-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Subject Etoposide Small molecule
Subject Melphalan Small molecule Other
Subject Topotecan Small molecule
Subject Vincristine Small molecule

Indications