Informations générales (source: ClinicalTrials.gov)
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated
Interventional
Phase 2
Institut Curie (Voir sur ClinicalTrials)
mars 2010
mars 2031
02 octobre 2025
Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according
to histopathological risk factors of the International Retinoblastoma Staging Working
Group.
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 13:12:23 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU NANCY | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Chu Bocage - 21079 - Dijon 3021372 - France | Contact (sur clinicalTrials) | ||||
| Chu de Grenoble - 38043 - Grenoble 3014728 - France | Contact (sur clinicalTrials) | ||||
| Chu de Poitiers - 86021 - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| Chu de Rennes - 35056 - Rennes 2983990 - France | Contact (sur clinicalTrials) | ||||
| Chu Toulouse - 31026 - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| Hopital Arnaud de Villeneuve - 34295 - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
| Hopital D'Enfants La Timone - 13385 - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Chu Amiens - 80054 - Amiens 3037854 - France | 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 | |||||
| Centre Oscar Lambret - 59020 - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| Chr Felix Guyon - 97405 - Saint-Denis 2980916 - La Réunion - France | Contact (sur clinicalTrials) | ||||
| Chu Angers - 49033 - Angers 3037656 - France | Contact (sur clinicalTrials) | ||||
| CHU CAEN - 14033 - Caen 3029241 - France | Contact (sur clinicalTrials) | ||||
| Chu de Nice - 06202 - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Chu de Rouen - 76031 - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| Chu Estaing - 63003 - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - 87042 - Limoges 2998286 - France | Contact (sur clinicalTrials) | ||||
| Chu Morvan - 29609 - Brest 3030300 - France | Contact (sur clinicalTrials) | ||||
| Chu Nantes - 44093 - Nantes 2990969 - France | Contact (sur clinicalTrials) | ||||
| Chu R; Pellegrin - 33076 - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| Chu Saint Etienne - 420555 - Saint-Etienne 2980291 - France | Contact (sur clinicalTrials) | ||||
| Chu Tours - 37044 - Tours 2972191 - France | Contact (sur clinicalTrials) | ||||
| Chur de Reims - 51100 - Reims 2984114 - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minioz - 25030 - Besançon 3033123 - France | Contact (sur clinicalTrials) | ||||
| Hoptial Hautepierre - 67098 - Strasbourg 2973783 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
1. Written informed consent - a signed informed consent and/or assent (as age
appropriate) will be obtained according to institutional guidelines;
2. Male or female ≥2 months and <10 years of age at the time of signing the informed
consent form;
3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary
enucleation
4. In case of post operative chemotherapy, patients must have adequate organ function:
- Adequate hematopoietic function Neutrophils>1.0x109/l, Platelets >100 x 109/l.
- Adequate hepatic function: grade II NCI CTC
- Adequate renal function: serum creatinemia <1.5 x ULN for age with normal
creatinine clearance estimated by SCHWARTZ formula
- Audiometry < Grade II de Brock.
- Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3
g/m²).
5. Patients affiliated to a Social Security Regimen or beneficiary of the same
6. No chemotherapy or radiotherapy prior to administration of the first dose of study
treatment for retinoblastoma or other tumor types
7. Without medical cons-indication to study drugs.
Exclusion Criteria:
- Bilateral and/or familial or trilateral retinoblastoma.
- Unilateral retinoblastoma with indication of primary chemotherapy before
enucleation:
- One or several surgical risk factors
- Buphthalmia Exophthalmia.
- Peri ocular inflammatory signs.
- Extraocular extension :
- Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa)
and or meningeal sheat optic nerve extension.
- Extrascleral extension
- Lymp nodes extension
- Unilateral retinoblastoma with possibility of conservative treatment:
- Metastatic extension at diagnosis
- One inclusion criteria non observed
- Uncontrolled medical conditions, psychological, familial, sociological, or
geographical conditions that do not permit compliance with the protocol