Neoplasms

Eye Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Retinoblastoma

Retinal Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Vincristine

Melphalan

Etoposide phosphate

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Group 1 - Multicentric non randomised, phase II study for patients with retinoblastoma (unilateral group A,B according to age, group C according to the age and the vitreous seeding or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat).

Treatment by chemoreduction (VP16, carboplatin) followed by Carboplatin + laser day 1 (chemothermotherapy) without laser treatment at day 8 (decreasing laser sessions) combined to local treatments from third course (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Group 2 - Multicentric non randomised, phase II study for the patients with bilateral very asymmetric disease (group D retinoblastoma on one of the eye, and the other amenable to a local treatment without chemotherapy) or unilateral presentation group D and groups B/C according to the age and vitreous seeding.

Treatment by Melphalan chemotherapy administered by superselective catheterization of the ophthalmic artery and combined to local treatments (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Group 3 - Multicentric non randomised, phase II study for the patients with bilateral group D retinoblastoma or with a group D retinoblastoma on the only remaining eye. Treatment by 6 cycles of three drugs (VP16, carboplatin, vincristin) regimen combined to local treatments from the third cycle (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Systemic treatment : Intravenous injections, 2 cycles (21 days)

VP16, carboplatin

intraarterial injections, 3 to 6 cycles (1 month)

Systemic treatment : Intravenous injections, 6 cycles (21 days)

VP16, carboplatin, vincristin

Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1

Carboplatin + laser day 1 (chemothermotherapy)

Laser (local treatment)

cryoapplication (local treatment)

I125 radioactive plaques (local treatment)

intravitreal Melphalan (local treatment)

Isabelle Aerts, MD

Catherine Devoldere, MD

Isabelle Pellier, MD

Véronique Laithier, MD

Celine De Bouyn-Icher, MD

Liana-Stephania Carausau, MD

Damien BODET, MD

Justyna Kanold, MD

Claire Briandet, MD

Dominique Plantaz, Prof.

Hélène Sudour-Bonnange, MD

Christophe Piguet, MD

Cécile Faure Conter, MD

Carole Coze, MD

Nicolas Sirvent, MD

Ludovic Mansuy, MD

Estelle Thebaud, MD

Marilyne Dupuy-Poiree, MD

Frederic Millot, MD

Claire Pluchart, MD

chloé Puiseux, MD

Pascale Schneider, Prof.

Jean-Louis Stephan, Prof.

Natacha Entz-Werle, MD

Anne-Isabelle Bertozzi-Salamon, MD

Pascale BLOUIN, MD

Michel Piotin, MD

Conservative treatments of retinoblastoma (RETINO 2011)

1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
2. -Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
3. - Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.

Conservative Treatments of Retinoblastoma

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

Number of fundus examination positives without clinical symptoms and number of patients treated after fundus examination-related treatment with a controlled disease.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 and types of adverse events occuring in order to reassess the benefice-risk scale (by Independent Data Monitoring Committee), for each arm of the study and for the whole study.

Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer.

Number of patients with uncontrolled disease (progression) and/or presenting Adverse Event(s) as assessed by CTCAE v4.0, related to intravitreal chemotherapy by Melphalan.

Time of scopies during ophthalmic arterial catheterism, doses delivered by the machine, doses received on skin.

Fondation Rothschild Paris

Institut Curie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Conservative Treatments of Retinoblastoma	NCT02866136	Retinoblastoma Children Retinal Neoplas...	VP16, carboplat... Melphalan VP16, carboplat... Carboplatin + l... Laser (local tr... cryoapplication... I125 radioactiv... intravitreal Me...	- 6 Years	Institut Curie
Conservative Treatments of Retinoblastoma	NCT02866136	Retinoblastoma Children Retinal Neoplas...	VP16, carboplat... Melphalan VP16, carboplat... Carboplatin + l... Laser (local tr... cryoapplication... I125 radioactiv... intravitreal Me...	- 6 Years	Institut Curie

Spots Global Cancer Trial Database for vp16, carboplatin