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RB SFCE 2009 : Adjuvant treatment in extensive unilateral retinoblastoma primary enucleated
EU CTIS ID: 2024-514844-10-00
What this study is testing
To determine DFS for unilateral retinoblastoma patients treated by primary enucleation followed by adjuvant treatment regarding histopathological risk factors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.