Informations générales (source: ClinicalTrials.gov)
Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018
Interventional
Phase 2/Phase 3
Institut Curie (Voir sur ClinicalTrials)
mars 2021
janvier 2036
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:14 | Contacter | |||
| HOPITAL FONDATION A. DE ROTHSCHILD | Raphaël BLANC | 21/06/2024 13:34:21 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FONDATION A. DE ROTHSCHILD | Raphaël BLANC, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| BESANCON CHU Hopital Jean Minjoz - 25030 - Besançon 3033123 - France | Sébastien KLEIN, MD | Contact (sur clinicalTrials) | |||
| BREST CHRU Hopital Morvan - 29609 - Brest 3030300 - France | Liana-Stéphania CARAUSU, MD | Contact (sur clinicalTrials) | |||
| CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP) - 63003 - Clermont-Ferrand 3024635 - France | Justyna KANOLD, MD | Contact (sur clinicalTrials) | |||
| DIJON CHU Hopital François Mitterand - 21079 - Dijon 3021372 - France | Claire BRIANDET, MD | Contact (sur clinicalTrials) | |||
| MONTPELLIER CHU Hopital Arnaud De Villeneuve - 34295 - Montpellier 2992166 - France | Nicolas SIRVENT, MD | Contact (sur clinicalTrials) | |||
| NANTES CHU Hopital Mere-Enfant - 44093 - Nantes 2990969 - France | LECULEE THEBAUD Estelle, MD | Contact (sur clinicalTrials) | |||
| NICE CHU Hopital Archet 2 - 06202 - Nice 2990440 - France | Gwenaëlle DUHIL DE BENAZE, MD | Contact (sur clinicalTrials) | |||
| Poitiers Chu - 86021 - Poitiers 2986495 - France | Frédéric MILLOT, MD | Contact (sur clinicalTrials) | |||
| Rennes Chu - 35056 - Rennes 2983990 - France | Chloé PUISEUX, MD | Contact (sur clinicalTrials) | |||
| TOURS CHU Hopital Clocheville - 37044 - Tours 2972191 - France | Pascale BLOUIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Amiens Chu - 80054 - Amiens 3037854 - France | Camille KHANFARD, MD | Contact (sur clinicalTrials) | |||
| Angers Chu - 49033 - Angers 3037656 - France | Isabelle PELLIER, MD | Contact (sur clinicalTrials) | |||
| Bordeaux Chu - 33076 - Bordeaux 3031582 - France | Céline DE BOUYN ICHER, MD | Contact (sur clinicalTrials) | |||
| CAEN CHU - 14033 - Caen 3029241 - France | Damien BODET, MD | Contact (sur clinicalTrials) | |||
| Grenoble Chu - 38045 - Grenoble 3014728 - France | Anne PAGNIER, MD | Contact (sur clinicalTrials) | |||
| Institut Curie - 75005 - Paris 2988507 - France | Livia LUMBROSO LE ROUIC, MD | Contact (sur clinicalTrials) | |||
| La Reunion - Chr Felix Guyon - 97405 - Saint-Denis 2980916 - La Réunion - France | Yves REGUERRE, MD | Contact (sur clinicalTrials) | |||
| LILLE Centre Oscar Lambret - 59037 - Lille 2998324 - France | Hélène SUDOUR BONNANGE, MD | Contact (sur clinicalTrials) | |||
| Limoges Chu - 87042 - Limoges 2998286 - France | Christophe PIGUET, MD | Contact (sur clinicalTrials) | |||
| LYON Centre Léon Bérard - 69373 - Lyon 2996944 - France | BENOIT DUMONT, MD | Contact (sur clinicalTrials) | |||
| Marseille Chu - 13385 - Marseille 2995469 - France | Carole COZE, MD | Contact (sur clinicalTrials) | |||
| Nancy Chu - 54500 - Vandœuvre-lès-Nancy 2970797 - France | Ludovic MANSUY, MD | Contact (sur clinicalTrials) | |||
| Reims Chu - 51092 - Reims 2984114 - France | Claire PLUCHART, MD | Contact (sur clinicalTrials) | |||
| Rouen Chu - 76000 - Rouen 2982652 - France | Cécile DUMESNIL DE MARICOURT, MD | Contact (sur clinicalTrials) | |||
| Saint Etienne Chu - 42055 - Saint-Etienne 2980291 - France | Jean-Louis STEPHAN, MD | Contact (sur clinicalTrials) | |||
| Strasbourg Chu - 67098 - Strasbourg 2973783 - France | Natacha ENTZ WERLE, MD | Contact (sur clinicalTrials) | |||
| Toulouse Chu - 31026 - Toulouse 2972315 - France | Anne-Isabelle BERTOZZI-SALAMON, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 previously treated with chemotherapy or radiotherapy for this or any
other cancer.
5. Patients with no contraindication to the proposed treatments.
6. Informed consent signed by parents or legal representative.
7. French Social Security System coverage.
Study 1 inclusion criteria:
8.1. Children aged from 6 months to 6 years. 9. Retinoblastoma in at least one eye,
deemed manageable with IAC in one side and without IV chemotherapy:
1. Unilateral Retinoblastoma classified as group B, C (if vitreous seeds < 3 mm), D or
E with no invasion of the anterior segment, and without massive tumor of more than
2/3 of the eye, eligible for conservative management, or
2. Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one
eye group D or E without invasion of the anterior segment or massive tumor of more
than 2/3 of the eye, eligible for IAC, and the other eye eligible for local
treatment only (without IAC).
Study 2 inclusion criteria:
8.2. Retinoblastoma eligible for conservative management although not manageable with
IAC:
1. Unilateral Retinoblastoma in children below 6 months of age, classified as Group A,
B, C or D, with or without vitreous seeding, compatible with conservative
management, or
2. Bilateral Retinoblastoma classified as group A, B, C D, or E without invasion of the
anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for
conservative management.
Exclusion Criteria:
Overall study non-inclusion criteria:
1. RB not eligible for conservative management :
1. Extra-ocular extension of the disease, or
2. Group E eyes with invasion of the anterior segment, and/or massive tumors of
more than 2/3 of the eye.
2. Patient older than 6 years of age.
3. Patients with another associated disease contra indicating systemic chemotherapy.
4. Previously treated retinoblastoma by chemotherapy.
5. Patients already treated for another malignant disease.
6. Patient with any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.
7. Patients whose parents have not accepted the treatment regimen after explanation of
it.
8. Contraindication to study drug mentioned in SmPC (Summary of Products
Characteristics) of the study drugs.
9. Inclusion in another experimental anti-cancer drug therapy.
Study 1 non-inclusion criteria:
10. Any contraindication or concomitant disease that would preclude the Study 1
treatment procedure and could delay treatment.
These patients should be eligible for Study 2.