Conservative Treatments of Retinoblastoma

Summary

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.

Conditions

• Retinoblastoma
• Children
• Retinal Neoplasm

Interventions

DRUG

VP16, carboplatin

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

DRUG

Melphalan

intraarterial injections, 3 to 6 cycles (1 month)

DRUG

VP16, carboplatin, vincristin

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

DRUG

Carboplatin + laser day 1 (chemothermotherapy)

Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1

DEVICE

Laser (local treatment)

DEVICE

cryoapplication (local treatment)

RADIATION

I125 radioactive plaques (local treatment)

DRUG

intravitreal Melphalan (local treatment)

Sponsors & Collaborators

• Fondation Rothschild Paris

  collaborator OTHER

• Institut Curie

  lead OTHER

Principal Investigators

• Isabelle Aerts, MD · Institut Curie - Paris - France

• Catherine Devoldere, MD · Amiens (FR), University College Hospital

• Isabelle Pellier, MD · Angers (FR), University College Hospital

• Véronique Laithier, MD · Besançon (FR), Jean Minjoz Hospital

• Celine De Bouyn-Icher, MD · Bordeaux (FR), Pellegrin Regional Hospital

• Liana-Stephania Carausau, MD · Brest (FR), University College Hospital

• Damien BODET, MD · Caen (FR), University College Hospital

• Justyna Kanold, MD · Clermont-Ferrand (FR), University College Hospital

• Claire Briandet, MD · Dijon (FR), Bocage University College Hospital

• Dominique Plantaz, Prof. · Grenoble (FR), University College Hospital

• Hélène Sudour-Bonnange, MD · Lille (FR), Oscar Lambret Center

• Christophe Piguet, MD · Limoges (FR), University College Hospital

• Cécile Faure Conter, MD · Lyon (FR), Leon Berard Center

• Carole Coze, MD · Marseille (FR), La Timone Children Hospital

• Nicolas Sirvent, MD · Montpellier (FR), Arnaud de Villeneuve Hospital

• Ludovic Mansuy, MD · Nancy (FR), University College Hospital

• Estelle Thebaud, MD · Nantes (FR), University College Hospital

• Marilyne Dupuy-Poiree, MD · Nice (FR), University College Hospital

• Frederic Millot, MD · Poitiers (FR), University College Hospital

• Claire Pluchart, MD · Reims (FR), Regional University College Hospital

• chloé Puiseux, MD · Rennes (FR), University College Hospital

• Pascale Schneider, Prof. · Rouen (FR), University College Hospital

• Jean-Louis Stephan, Prof. · Saint-Etienne (FR), University College Hospital

• Natacha Entz-Werle, MD · Strasbourg (FR), University College Hospital

• Anne-Isabelle Bertozzi-Salamon, MD · Toulouse (FR), Children Hospital

• Pascale BLOUIN, MD · Tours (FR), University College Hospital

• Michel Piotin, MD · Paris (FR), Adolphe Rothschild Ophtalmologic Foundation

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2023-01-31

Completion

2035-09-30

Countries

• France

Study Locations