Informations générales (source: ClinicalTrials.gov)
Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018 (RETINO2018)
Interventional
Phase 2/Phase 3
Institut Curie (Voir sur ClinicalTrials)
mars 2021
janvier 2036
29 juin 2024
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 | 04/09/2024 13:49:45 | Contacter | |||
| HOPITAL FONDATION A. DE ROTHSCHILD | Raphaël BLANC | 21/06/2024 13:34:21 | Contacter | ||
| 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 - France | Camille KHANFARD, MD | Contact (sur clinicalTrials) | |||
| Angers Chu - 49033 - Angers - France | Isabelle PELLIER, MD | Contact (sur clinicalTrials) | |||
| BESANCON CHU Hopital Jean Minjoz - 25030 - Besancon - France | Sébastien KLEIN, MD | Contact (sur clinicalTrials) | |||
| Bordeaux Chu - 33076 - Bordeaux - France | Céline DE BOUYN ICHER, MD | Contact (sur clinicalTrials) | |||
| BREST CHRU Hopital Morvan - 29609 - Brest - France | Liana-Stéphania CARAUSU, MD | Contact (sur clinicalTrials) | |||
| CAEN CHU - 14033 - Caen - France | Damien BODET, MD | Contact (sur clinicalTrials) | |||
| CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP) - 63003 - Clermont-Ferrand - France | Justyna KANOLD, MD | Contact (sur clinicalTrials) | |||
| DIJON CHU Hopital François Mitterand - 21079 - Dijon - France | Claire BRIANDET, MD | Contact (sur clinicalTrials) | |||
| Grenoble Chu - 38045 - Grenoble - France | Anne PAGNIER, MD | Contact (sur clinicalTrials) | |||
| La Reunion - Chr Felix Guyon - 97405 - Saint-Denis - La Réunion - France | Yves REGUERRE, MD | Contact (sur clinicalTrials) | |||
| LILLE Centre Oscar Lambret - 59037 - Lille - France | Hélène SUDOUR BONNANGE, MD | Contact (sur clinicalTrials) | |||
| Limoges Chu - 87042 - Limoges - France | Christophe PIGUET, MD | Contact (sur clinicalTrials) | |||
| LYON Centre Léon Bérard - 69373 - Lyon - France | BENOIT DUMONT, MD | Contact (sur clinicalTrials) | |||
| Marseille Chu - 13385 - Marseille - France | Carole COZE, MD | Contact (sur clinicalTrials) | |||
| MONTPELLIER CHU Hopital Arnaud De Villeneuve - 34295 - Montpellier - France | Nicolas SIRVENT, MD | Contact (sur clinicalTrials) | |||
| Nancy Chu - 54500 - Vandoeuvre Les Nancy - France | Ludovic MANSUY, MD | Contact (sur clinicalTrials) | |||
| NANTES CHU Hopital Mere-Enfant - 44093 - Nantes - France | LECULEE THEBAUD Estelle, MD | Contact (sur clinicalTrials) | |||
| NICE CHU Hopital Archet 2 - 06202 - Nice - France | Gwenaëlle DUHIL DE BENAZE, MD | Contact (sur clinicalTrials) | |||
| Poitiers Chu - 86021 - Poitiers - France | Frédéric MILLOT, MD | Contact (sur clinicalTrials) | |||
| Reims Chu - 51092 - Reims - France | Claire PLUCHART, MD | Contact (sur clinicalTrials) | |||
| Rennes Chu - 35056 - Rennes - France | Chloé PUISEUX, MD | Contact (sur clinicalTrials) | |||
| Rouen Chu - 76000 - Rouen - France | Cécile DUMESNIL DE MARICOURT, MD | Contact (sur clinicalTrials) | |||
| Saint Etienne Chu - 42055 - Saint Etienne - France | Jean-Louis STEPHAN, MD | Contact (sur clinicalTrials) | |||
| Strasbourg Chu - 67098 - Strasbourg - France | Natacha ENTZ WERLE, MD | Contact (sur clinicalTrials) | |||
| Toulouse Chu - 31026 - Toulouse - France | Anne-Isabelle BERTOZZI-SALAMON, MD | Contact (sur clinicalTrials) | |||
| TOURS CHU Hopital Clocheville - 37044 - Tours - France | Pascale BLOUIN, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 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.
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.
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.