NL-OMON54695招募中3 期
An international clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma. - SIOP Ependymoma II
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
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（—）
入选标准
- •OVERALL PROGRAM: • Main residence in one of the participating countries. • Age < 22 years old at 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) for collection and transfer of biological samples. • 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.STRATUM I: • Age>12 months and < 22 years at time of study entry. • No residual measurable ependymoma based on the central neuroradiological 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). • Patients must be affiliated to a Social Security System in countries where this is mandatory.STRATUM 2: • Age > 12 months and < 22 years at time of study entry. • Residual non-reoperable measurable ependymoma based on the central neuroradiological review where: - 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
排除标准
- •Exclusion criteria for the overall program
- •- Patient with subependymomas and ependymoblastomas.
- •- Primary diagnosis predating the opening of SIOP Ependymoma II (Apr 29th
- •2015)Exclusion criteria for interventional strata 1,2 and 3:
- •- 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 applicable stratum according
- •to the SmPCs,Additional exlusion criterion for stratum 1 and 2:
- •- Patient for whom imaging remains RX despite all effort to clarify the MRI
- •conclusion.Additional exclusion criteria for stratum 3:
- •- 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 Exclusion
- •criteria observational study:
- •- Tumour entity other than primary ependymoma
- •- Patient with subependymomas and ependymoblastomas
- •- Primary diagnosis predating the activation ofteh SIOP Ependymoma II program
- •(Apr 29th 2015)Cÿëý**ù*
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