Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
- 试验地点
- 27
- 主要终点
- Rate of extra ocular relapses
研究概览
简要总结
Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
详细描述
Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
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Low risk group :
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No optic nerve involvement.
-
Intra and prelaminar involvement
-
No choroidal involvement.
-
Minimal superficial choroidal involvement .
-
Intermediate risk group, 2 sub groups :
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Sub group 1 :
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Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement
-
Anterior segment involvement.
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Intrascleral involvement.
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Sub Group 2 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines;
- •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
- •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).
- •Patients affiliated to a Social Security Regimen or beneficiary of the same
- •No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
- •Without medical cons-indication to study drugs.
排除标准
- •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
研究组 & 干预措施
Low risk group
No treatment
干预措施: Observation (Other)
Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
干预措施: Etoposide (Drug)
Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
干预措施: Carboplatin (Drug)
Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
干预措施: Vincristine (Drug)
Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
干预措施: Cyclophosphamide (Drug)
Intermediate risk sub group 2
2 courses of Vincristin and Carboplatin
干预措施: Vincristine (Drug)
Intermediate risk sub group 2
2 courses of Vincristin and Carboplatin
干预措施: Carboplatin (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Orbital irradiation (Radiation)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Etoposide (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Carboplatin (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Thiotepa (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Vincristine (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Cyclophosphamide (Drug)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Cytapheresis (Procedure)
High risk group
-
Orbital irradiation
-
3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :
-
Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
-
Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
-
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
-
High dose chemotherapy :
-
Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
-
Peripheral bood stem cell transplantation.
干预措施: Peripheral bood stem cell transplantation (Procedure)
结局指标
主要结局
Rate of extra ocular relapses
时间窗: 5 years
次要结局
- Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.(5 years)
- Number of patient with secondary bilateralisation(5 years)
- Evaluate the different histopathological risk factors frequency(5 years)
- To determine tumors genomic(at the inclusion)
- Evaluate sensitivity of MRI in detecting extra ocular extension(At the inclusion)