RB SFCE 2009 : Adjuvant treatment in extensive unilateral retinoblastoma primary enucleated

Phase 1

Conditions: Retinoblastoma
MedDRA version: 20.0Level: PTClassification code: 10038916Term: Retinoblastoma Class: 100000004864
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: CTIS2024-514844-10-00

Lead Sponsor: Institut Curie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 185

Inclusion Criteria

Male or female =2 months and <10 years of age at the time of signing the informed consent form;, Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation, No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor type., Without medical cons-indication to study drugs., Long term follow –up possible., Written informed consent – a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines, Patients affiliated to a Social Security Regimen or beneficiary of the same, In case of post operative chemotherapy, patients must have adequate organ function: a- Adequate hematopoietic function Neutrophils>1.0x109/l, Platelets >100 x 109/l. b- Adequate hepatic function: grade II NCI CTC. c- Adequate renal function: serum creatinemia <1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula. d- Audiometry < Grade II de Brock. e-Echocardiography normal in case of high dose cyclophophamide chemotherapy (3 g/m²).

Exclusion Criteria

Bilateral and/or familial or trilateral retinoblastoma., Unilateral retinoblastoma with indication of primary chemotherapy before enucleation: 1- One or several surgical risk factors : - Buphtalmia Exophtalmia. - Peri ocular inflamatory signs. 2- Extraocular extension : - Radiological retrolaminar extension (more than 3 mm behind the lamina cribosa) and or meningeal sheat optic nerve extension. - Extrascleral extension. - Lymp nodes extension., Unilateral retinoblastoma with possibility of conservative treatment: - lesion(s) taking up less than 2/3 of the eyeball. - preservation of macula and papilla., 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.