Informations générales (source: ClinicalTrials.gov)
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated
Interventional
Phase 2
Institut Curie (Voir sur ClinicalTrials)
mars 2010
septembre 2030
29 juin 2024
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 | 04/09/2024 13:49:54 | 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 Leon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| Chr Felix Guyon - 97405 - Saint-Denis - La Réunion - France | Contact (sur clinicalTrials) | ||||
| Chu Angers - 49033 - Angers - France | Contact (sur clinicalTrials) | ||||
| Chu Bocage - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU CAEN - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Chu de Grenoble - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Chu de Nice - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Chu de Poitiers - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Chu de Rennes - 35056 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Chu de Rouen - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Chu Estaing - 63003 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Chu Morvan - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| Chu Nancy - 54500 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Chu Nantes - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Chu R; Pellegrin - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Chu Saint Etienne - 420555 - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
| Chu Toulouse - 31026 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Chu Tours - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Chur de Reims - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hopital Arnaud de Villeneuve - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hopital D'Enfants La Timone - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minioz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Chu Amiens - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Hoptial Hautepierre - 67098 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
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.
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.
- 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