DRKS00023783招募中3 期
An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) includingA randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy - SIOPE ATRT01
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- one 至 18 Years（—）
- 性别
- All
入选标准
- •1. Enrolled in the umbrella trial
- •2. Received 3 courses of induction chemotherapy according to protocol and following induction in SD or better
- •3. Expected age 12-35 months at time of consolidation therapy (RT or HDCT)
- •4. Written informed consent and/or assent for randomization according to national legislation
- •5. Central review of pathology confirmed ATRT
- •6. MRI (magnetic resonance imaging) and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
- •7. Alanine transaminase (ALT) or aspartate transaminase (AST) =3.0 x upper limit of normal (ULN) and bilirubin =1.5 x ULN
- •8. Creatinine = 1.5 x ULN and measured glomerular filtration rate (GFR) defined age-related values according to national standard methods.
- •9. Ejection fraction (EF) =50% or fractional shortening (FS) =29% by echocardiography
- •1. Enrolled in the umbrella trial
- •2. Received 3 courses of induction chemotherapy according to the protocol
- •3. Radiotherapy not admissible (e.g. <12 months or other contraindications)
- •4. Not eligible for the randomized trial (Part A) (e.g. refusal of randomization)
- •5. Written informed consent and/or assent for inclusion according to national legislation
- •6. Central review of pathology confirmed ATRT
- •7. MRI and cerebrospinal fluid examination after 3 courses of chemotherapy and, if applicable, later showing clinically significant sensitivity to chemotherapy (central review – national or regional centre)
- •8. ALT or AST =3.0 x ULN, bilirubin = 1.5 x ULN
- •9. Creatinine = 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods
- •10. EF =50% or FS =29% by echocardiography.
- •1. Enrolled in the umbrella trial
- •2. Received 3 courses of induction chemotherapy according to the protocol
- •3. Aged 36 months or above OR
- •4. HDCT not possible OR
- •5. Not eligible for the randomized trial (Part A)
- •6. Written informed consent and/or assent for inclusion according to national legislation
- •7. Central review of pathology confirmed ATRT
- •8. MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
- •9. ALT or AST =3.0 x ULN, bilirubin = 1.5 x ULN
- •10. Creatinine = 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods.
- •11. EF =50% or FS =29% by echocardiography
排除标准
- •1. Previous or concomitant tumour directed chemotherapy, RT or targeted therapy, other than within the SIOPE ATRT01 trial
- •2. Metastatic disease at primary diagnosis
- •3. At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy
- •4. History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive care:
- •a. Sustained ventricular tachyarrhythmia
- •b. Any ventricular fibrillation or torsade de pointes,
- •5. At time of inclusion bradycardia defined as persistent heart rate < 50/minute if uncontrolled despite optimal supportive therapy
- •Screening electrocardiogram (ECG) with a QT corrected by Bazett’s (QTcB) >450msec minute if uncontrolled despite optimal supportive therapy
- •6. Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg)
- •7. Any contraindication to any planned chemotherapy drug according to summary of medical product chart (SmPC)
- •8. Known active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immune-deficiency virus (HIV) infection
- •9. Participation in another interventional therapeutic clinical trial
- •10. Patients on coumarin-derivative anticoagulants
- •11. History of thrombosis or sinusoidal obstruction syndrome (SOS)
- •12. Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
- •13. Neutropenia (absolute neutrophil count (ANC) <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
- •14. Synchronous multifocal rhabdoid tumours
- •15. Hypersensitivity to the active compounds or other excipients contained in one of the investigational medical products listed in the SmPC.
- •1. Previous or concomitant tumour directed chemotherapy, radiotherapy or small molecule therapy, other than within the SIOPE ATRT01 trial
- •2. At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy
- •3. History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive therapy:
- •a. Sustained ventricular tachyarrhythmia
- •b. Any ventricular fibrillation or torsade de pointes
- •c. Current bradycardia defined as heart rate < 50/minute
- •d. Screening ECG with a QTcB >450msec
- •4. Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg)
- •5. Any contraindication to any planned chemotherapy drug according to SmPC
- •6. Known active HBV, HCV or HIV infection
- •7. Participation in another interventional therapeutic clinical trial
- •8. Patients on coumarin-derivative anticoagulants
- •9. History of thrombosis or SOS
- •10. Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
- •11. Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
- •12. Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC.
- •1. Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial
- •2. Any contraindication to any planned chemotherapy drug according to SmPC
- •3. Participation in another interventional therapeutic clinical trial
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