EUCTR2013-002766-39-GR进行中（未招募）1 期
An international clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma. - SIOP EP II
Centre Léon Bérard0 个研究点目标入组 480 人开始时间: 2021年3月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •OVERALL PROGRAM:
- •Main residence in one of the participating countries
- •Age < 22 years old at the diagnosis
- •Histological diagnosis of intracranial or spinal, localized or metastatic, ependymoma according to local pathologist (all WHO grades) including: myxopapillary ependymoma, ependymoma (papillary, clear-cell, tanycytic), ependymoma RELA fusion-positive or anaplastic ependymoma,
- •Delivery to national referral pathology center of FFPE tumour tissue blocks,
- •Written informed consent (staging),
- •All patients and/or their parents or legal guardians willing and able to comply with protocol schedule and agree to sign a written informed consent,
- •Patients must be affiliated to a Social Security System in countries where this is mandatory.
- •Age>12 months and < 22 years at time of study entry,
- •No residual measurable ependymoma based on the central neuro-radiological review This includes:
- •R0: No residual tumour on postoperative MRI in accordance with the neurosurgical report
- •R1: No residual tumour on MRI but description of a small residual tumour by the neurosurgeon.
- •R2: small residual tumour on MRI with the maximum diameter below 5mm in any direction
- •Newly diagnosed intracranial ependymoma of WHO grade II-III confirmed by central pathological review,
- •No metastasis on spinal MRI and on CSF cytology assessments,
- •No previous radiotherapy,
- •No previous chemotherapy,
- •No co-existent unrelated disease at the time of study entry that would render the patient unable to receive chemotherapy,
- •No medical contraindication to radiotherapy, and chemotherapy,
- •No signs of infection,
- •Adequate bone marrow, liver and renal function (detailled in protocol)
- •Post-menarchal female not pregnant or nursing (breast feeding) and with a negative beta-HCG pregnancy test prior to commencing the trial,
- •Males and females of reproductive age and childbearing potential with effective contraception for the duration of their treatment and 6 months after the completion of their treatment,
- •Patients and/or their parents or legal guardians must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures of the stratum 1,
- •Written informed consent (stratum 1).
- •Age > 12 months and < 22 years at time of study entry,
- •No residual measurable ependymoma based on the central neuro-radiological review. This includes:
- •R3: Residual tumour that can be measured in 3 planes,
- •R4: Size of the residual tumour not differing from the preoperative status (e.g. after biopsy)
- •Newly diagnosed intracranial ependymoma of WHO grade II-III confirmed by central pathological review,
- •No metastasis on spinal MRI and on CSF cytology assessments,
- •No previous radiotherapy,
- •No previous chemotherapy,
- •No co-existent unrelated disease at the time of study entry that would render the patient unable to receive chemotherapy,
- •No medical contraindication to radiotherapy, and chemotherapy,
- •No signs of infection,
- •Adequate bone marrow, liver and renal functions (detailled in protocol)
- •Post-menarchal female not pregnant or nursing (breast feeding) and with a negative beta-HCG pregnancy test prior to commencing the trial,
- •Males and females of reproductive age and childbearing potential with effective contraception for the duration of their treatment and 6 months after the completion of their treatment,
- •Patients and/or their parents or legal guardians must be willing and able to comply with scheduled visits, treatment plan, laborator
排除标准
- •OVERALL PROGRAM
- •Patient with subependymomas and ependymoblastomas,
- •Primary diagnosis predating the activation of the SIOP Ependymoma II program (Apr 29th 2015).
- •Tumour entity other than primary intracranial ependymoma,
- •Patients with WHO grade I ependymoma including myxopapillary variant,
- •Patients with spinal cord location of the primary tumour,
- •Participation within a different trial for treatment of ependymoma,
- •Concurrent treatment with any anti-tumour agents,
- •Inability to tolerate chemotherapy,
- •Unable to tolerate intravenous hydration,
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the investigator,
- •Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion,
- •Contraindication to one of the IMP used in the stratum 1 according to the SmPCs,
- •Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion.
- •Tumour entity other than primary intracranial ependymoma,
- •Patients with WHO grade I ependymoma including myxopapillary variant,
- •Patients with spinal cord location of the primary tumour,
- •Participation within a different trial for treatment of ependymoma,
- •Concurrent treatment with any anti-tumour agents,
- •Inability to tolerate chemotherapy,
- •Unable to tolerate intravenous hydration,
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the investigator,
- •Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion,
- •Contraindication to one of the IMP used in the stratum 2 according to the SmPCs,
- •Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion.
- •Tumour entity other than primary intracranial ependymoma,
- •Patients with WHO grade I ependymoma including myxopapillary variant ,
- •Patients with spinal cord location of the primary tumour,
- •Participation within a different trial for treatment of ependymoma,
- •Concurrent treatment with any anti-tumour agents,
- •Inability to tolerate chemotherapy,
- •nable to tolerate intravenous hydration,
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the investigator,
- •Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion,
- •Pre-existing severe hepatic and/or renal damage,
- •Family history of severe epilepsy in immediate family siblings,
- •Presence of previously undiagnosed mitochondrial disorder detected by screening as part of trial,
- •Elevated blood ammonium level = 1.5 x upper limit of the normal ,
- •Elevated blood lactate level = 1.5 x upper limit of the normal,
- •Contraindication to one of the IMP used in the stratum 3 according to the SmPCs.
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