2024-512222-28-00招募中3 期
SIOP Ependymoma Program II: An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with ependymoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 876
- 试验地点
- 141
- 主要终点
- Overall program : Gross Total Resection (GTR) rate
研究概览
简要总结
Overall program : To determine whether the assessment of residual disease can be improved by a centralized review of post-operative MRI and whether such review increases the rate of complete resection compared to historical controls. Does central neurosurgical and radiological review increase resection rates? Stratum 1: To test the hypothesis that there will be an improvement in progression-free survival in patients who receive 16 weeks chemotherapy (VEC+CDDP) following surgical resection and conformal radiotherapy when compared to those that undergo surgical resection and radiotherapy alone. Stratum 2: To compare the activity of 2 post-operative chemotherapy schedules, VEC or VEC+HD-MTX in patients who have incompletely resected tumour. Stratum 3: To evaluate the progression free survival in children unable to receive radiation therapy and who receive valproate, as a histone deacetylase inhibitor in addition to the primary chemotherapy strategy when compared to those that undergo chemotherapy without valproate.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Overall program : Main residence in one of the participating countries.
- •All interventional strata : No previous chemotherapy (except steroids).
- •All interventional strata : No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry that would render the patient unable to receive chemotherapy.
- •All interventional strata : No signs of infection.
- •All interventional strata : Adequate bone marrow, liver and renal function (detailed in protocol).
- •All interventional strata : 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.
- •All interventional strata : Written informed consent (specific to the stratum)
- •Stratum 1 and 2 : Age > 12 months and < 22 years at time of study entry.
- •Stratum 1 and 2 : No metastasis on spinal MRI and on CSF cytology assessments.
- •Stratum 1 and 2 : No medical contraindication to radiotherapy, and chemotherapy.
- •Stratum 1 and 2 : Post-menarchal female not pregnant or nursing (breast feeding) and with a negative beta-HCG pregnancy test prior to commencing the trial.
- •Overall program : Age < 22 years old at the diagnosis.
- •Stratum 1 and 2 : 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.
- •Stratum 1 : 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.
- •Stratum 2 : Residual non reoperable measurable ependymoma based on 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).
- •Stratum 3 : Children younger than 12 months at time of entry to study or any patient ineligible to receive radiotherapy due to age at diagnosis, tumour location or clinician / parent decision and according to national criteria.
- •Stratum 3 : No medical contraindication to chemotherapy.
- •Overall program : Histological diagnosis of intracranial or spinal, localized or metastatic, ependymoma according to local pathologist (all WHO grades).
- •Overall program : Delivery to national referral pathology center of FFPE tumour tissue blocks (or at least twenty 4 µm sections on charged slides with sufficient interpretable material and at least ten 10 µm curls in an Eppendorf tube).
- •Overall program : Written informed consent (specific to staging) for data and study biological samples collection.
- •Overall program : 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.
- •Overall program : Patients must be affiliated to a Social Security System in countries where this is mandatory.
- •All interventional strata : Newly diagnosed intracranial ependymoma of WHO grade II-III confirmed by central pathological review.
- •All interventional strata : No previous radiotherapy.
排除标准
- •Overall program : Patient with subependymomas and ependymoblastomas.
- •All interventional strata : Concurrent treatment with any anti-tumour agents.
- •All interventional strata : Unable to tolerate intravenous hydration.
- •All interventional strata : Inability to tolerate chemotherapy.
- •Stratum 1 and 2 : Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion.
- •Stratum 3 : Pre-existing severe hepatic and/or renal damage.
- •Stratum 3 : Family history of severe epilepsy in immediate family siblings.
- •Stratum 3 : Presence of previously undiagnosed mitochondrial disorder detected by screening as part of trial.
- •Stratum 3 : Elevated blood ammonium level ≥ 1.5 x upper limit of the normal.
- •Stratum 3 : Elevated blood lactate level ≥ 1.5 x upper limit of the normal.
- •Overall program : Primary diagnosis predating the activation of the SIOP Ependymoma II program (Apr 29th 2015).
- •All interventional strata : Tumour entity other than primary intracranial ependymoma.
- •All interventional strata : Patients with WHO grade I ependymoma including myxopapillary variant.
- •All interventional strata : Patients with spinal cord location of the primary tumour.
- •All interventional strata : 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.
- •All interventional strata : Participation within a different trial for treatment of ependymoma.
- •All interventional strata : Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion.
- •All interventional strata : Contraindication to one of the IMP used in the stratum according to the SmPCs (see protocol).
结局指标
主要结局
Overall program : Gross Total Resection (GTR) rate
Overall program : Gross Total Resection (GTR) rate
Stratum 1 and 3 : Progression Free Survival (PFS)
Stratum 1 and 3 : Progression Free Survival (PFS)
Stratum 2 : Number of treatment responders (according to central radiological review)
Stratum 2 : Number of treatment responders (according to central radiological review)
次要结局
- Overall program : Second look surgery rate
- All interventional strata : Efficacy in each molecular sub-group in terms of PFS and OS
- All interventional strata : Overall Survival
- All interventional strata : Neuroendocrine outcomes
- All interventional strata : Neuropsychological outcomes
- All interventional strata : Quality of Survival
- All interventional strata : Adverse events (CTCAE v4.03)
- Stratum 2 : Proportion of patients in whom the result of the central radiological review confirms the local review.
- Stratum 2 : Progression Free Survival
- Stratum 3 : Radiotherapy-free survival rate
研究者
Dr Pierre LEBLOND
Scientific
Centre Leon Berard
研究点 (141)
Loading locations...
相似试验
进行中（未招募）
不适用
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with EpendymomaEUCTR2013-002766-39-ESCENTRE LEON BERARD480
进行中（未招募）
1 期
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with EpendymomaHistological diagnosis of intracranial localized ependymoma, including ependymoma variants: myxopapillary ependymoma, ependymoma (papillary, clear-cell, tanycytic), ependymoma RELA-fusion positive or anaplastic .MedDRA version: 20.0Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002766-39-BECENTRE LEON BERARD480
进行中（未招募）
1 期
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with Ependymomaewly diagnosed with an intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary, myxopapillary, clear-cell and tanycytic) or anaplastic ependymoma.MedDRA version: 16.1Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002766-39-NOCENTRE LEON BERARD480
进行中（未招募）
1 期
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults affetti da Ependymomaewly diagnosed with an intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary, myxopapillary, clear-cell and tanycytic) or anaplastic ependymoma.MedDRA version: 16.1Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002766-39-ITCENTRE LEON BERARD480
进行中（未招募）
1 期
SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults with EpendymomaEUCTR2013-002766-39-FICENTRE LEON BERARD480