Neoplasms

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Diseases and Abnormalities at or Before Birth

Rare Diseases

Retinoblastoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

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Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Neuroepithelioma

Antineoplastic Agents

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Central Nervous System Depressants

Micronutrients

Anti-Infective Agents

Carboplatin

Etoposide

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Topotecan

Vincristine

Melphalan

Etoposide phosphate

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Cadexomer iodine

Enzyme Inhibitors

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Antineoplastic Agents, Alkylating

Alkylating Agents

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Immunologic Factors

Topoisomerase I Inhibitors

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.

Neoadjuvant chemotherapy involves 2 to 6 cycles of combined etoposide, carboplatin and vincristine in association with ophthalmologic treatments.

IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team.

Melphalan or Melphalan + Topotecan

2 to 6 cycles of combined etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy : thermotherapy and/or cryotherapy and/or iodine-125 plaques and/or intravitreal chemotherapy injections

etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy

Chemothermotherapy : Intravenous injection by carboplatin

Carboplatin administered on Day 1

Thermotherapy after carboplatin administered on Day 1

Thermotherapy (local treatment)

Cryotherapy (local treatment)

Iodine-125 plaques (local treatment)

Intravitreal Melphalan chemotherapy injections (local treatment)

Livia LUMBROSO LE ROUIC, MD

Christine FOULON, PhD

Yves REGUERRE, MD

Camille KHANFARD, MD

Isabelle PELLIER, MD

Sébastien KLEIN, MD

Céline DE BOUYN ICHER, MD

Liana-Stéphania CARAUSU, MD

Damien BODET, MD

Justyna KANOLD, MD

Claire BRIANDET, MD

Anne PAGNIER, MD

Hélène SUDOUR BONNANGE, MD

Christophe PIGUET, MD

Christophe Christophe PIGUET, MD

BENOIT DUMONT, MD

Carole COZE, MD

Nicolas SIRVENT, MD

LECULEE THEBAUD Estelle, MD

Gwenaëlle DUHIL DE BENAZE, MD

Isabelle AERTS, MD

LIvia LUMBROSO LE ROUIC, MD

Raphaël BLANC, MD

Frédéric MILLOT, MD

Claire PLUCHART, MD

Chloé PUISEUX, MD

Cécile DUMESNIL DE MARICOURT, MD

Jean-Louis STEPHAN, MD

Natacha ENTZ WERLE, MD

Anne-Isabelle BERTOZZI-SALAMON, MD

Pascale BLOUIN, MD

Ludovic MANSUY, MD

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.

Primary objective of the studies:

* Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study);
* Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic trématent or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).

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

Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Rate of eye preservation in the 2 treatments' arms

Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension

Percentage of patients with at least one grade-3 or -4 toxicity (CTCAE v. 5.0)

Rate of specific grade 3-4 toxicity (CTCAE v. 5.0)

Percentage of patients with relapse within 24 months after inclusion, broken down into: Local relapse, Extra-ocular relapse

Percentage of patients with second malignant tumor within 24 months after study inclusion

Additional assessment of visual function at follow-up: Percentage of patients at each of the four levels of visual acuity according to WHO criteria

Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A) measures on retina

Rate of children able to attend the common primary school : without specific help or with the help of a dedicated person and/or with specific features to facilitate reading and writing

Fondation Rothschild Paris

Institut Curie

Spots Global Cancer Trial Database for ocular conservative treatment in retinoblastoma