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

Recruiting Phase 2 Phase 3 Interventional Study
Retinoblastoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months – 6
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
225 (estimated)
Sponsor
Institut Curie · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Overall study inclusion criteria: 1. Newly diagnosed retinoblastoma (RB). 2. Retinoblastoma with at least one eye eligible for conservative management. 3. Patients likely to be compliant with the study requirements and visits, including late follow-up. 4. Patients not previousl…
Contacts

Livia LUMBROSO LE ROUIC, MD

+33(0)144324163

livia.lumbroso-lerouic@curie.fr

CONTACT

Christine FOULON, PhD

+33(0)147111733

drci.promotion@curie.fr

CONTACT