CTIS2022-501456-28-00招募中1 期
An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including a randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy - SIOPEATRT01
GPOH gGmbH0 个研究点目标入组 225 人开始时间: 2023年5月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Age at diagnosis less than 18 years, Part A: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre), Part A: ALT or AST =3.0 x ULN, bilirubin = 1.5 x ULN, Part A: Creatinine = 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods, Part A: EF =50% or FS =29% by echocardiography, Part B: Enrolled in the umbrella trial, Part B: Received 3 courses of induction chemotherapy according to the protocol, Part B: Radiotherapy not admissible (e.g. <12 months or other contraindications), Part B: Not eligible for the randomized trial (Part A) (e.g. refusal of randomization), Part B: Written informed consent and/or assent for inclusion according to national legislation, Part B: Central review of pathology confirmed ATRT, Pathology compatible with ATRT and INI1 loss or SMARCB1 or SMARCA4 deficiency confirmed by local pathology lab, Part B: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing clinically significant sensitivity to chemotherapy (central review – national or regional centre), Part B: ALT or AST =3.0 x ULN, bilirubin = 1.5 x ULN, Part B: Creatinine = 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods, Part B: EF =50% or FS =29% by echocardiography, Part C: Enrolled in the umbrella trial, Part C: Received 3 courses of induction chemotherapy according to the protocol, Part C: Aged 36 months or above OR HDCT not possible OR Not eligible for the randomized trial (Part A), Part C: Written informed consent and/or assent for inclusion according to national legislation, Part C: Central review of pathology confirmed ATRT, Part C: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre), Written informed consent and/or assent for study participation according to national legislation, Part C: ALT or AST =3.0 x ULN, bilirubin = 1.5 x ULN, Part C: Creatinine = 1.5 x ULN and measured GFR within published defined age-related values according to national standard methods, Part C: EF =50% or FS =29% by echocardiography, Patient agrees to use effective contraception whilst on treatment, Part A: Enrolled in the umbrella trial, Part A: Received 3 courses of induction chemotherapy according to the protocol and following induction in SD or better, Part A: Expected age 12-35 months at time of consolidation therapy (RT or HDCT), Part A: Written informed consent and/or assent for randomization according to national legislation, Part A: Central review of pathology confirmed ATRT
排除标准
- •Part A: Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial, Part A: History of thrombosis or SOS, Part A: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal), Part A: Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy, Part A: Synchronous multifocal rhabdoid tumours, Part A: Hypersensitivity to the active compounds or other, Part B: Previous or concomitant tumour directed chemotherapy, radiotherapy or small molecule therapy, other than within the SIOPE ATRT01 trial, Part B: At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy, Part B: 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, Part B: Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg), Part B: Any contraindication to any planned chemotherapy drug according to SmPC, Part A: Metastatic disease at primary diagnosis, Part B: Known active HBV, HCV or HIV infection, Part B: Participation in another interventional therapeutic clinical trial, Part B: Patients on coumarin-derivative anticoagulants, Part B: History of thrombosis or SOS, Part B: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal), Part B: Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy, Part B: Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC, Part C: Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial, Part C: Any contraindication to any planned chemotherapy drug according to SmPC, Part C: Participation in another interventional therapeutic clinical trial, Part A: 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, Part C: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal), Part C: Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC, Part A: At time of inclusion bradycardia defined as persistent heart rate < 50/minute if uncontrolled despite optimal supportive therapy Screening ECG with a QTcB >450msec minute if uncontrolled despite optimal supportive therapy, Part A: Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure =25mmHg), Part A: Any contraindication to any planned chemotherapy drug according to SmPC, Part A: Known active HBV, HCV or HIV infection, Part A: Participation in another interventional therapeutic clinical trial, Part A: Patients on coumarin-derivative anticoagulants
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