2024-514844-10-00招募中2 期
RB SFCE 2009 : Adjuvant treatment in extensive unilateral retinoblastoma primary enucleated
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 27
- 主要终点
- Rate of extra ocular relapses
研究概览
简要总结
To determine DFS for unilateral retinoblastoma patients treated by primary enucleation followed by adjuvant treatment regarding histopathological risk factors
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Rate of extra ocular relapses
Rate of extra ocular relapses
次要结局
- To determine tumors genomic.
- Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation.
- Number of patient with secondary bilateralisation
- Evaluate the different histopathological risk factors frequency.
- Evaluate sensitivity of MRI in detecting extra ocular extension.
研究者
Isabelle AERTS
Scientific
Institut Curie
研究点 (27)
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