EUCTR2020-003063-26-FR进行中（未招募）1 期
PersoMed-I: Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly Diagnosed Medulloblastoma - PersoMed-I
European Organisation for Research and Treatment of0 个研究点目标入组 205 人开始时间: 2023年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 205
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
- 性别
- All
入选标准
- •Step 1: Registration
- •Before patient registration/randomization/enrollment, written informed consent must be given according to ICH/GCP, and national/local regulations. For patients under age of legal consent, consent has to be obtained from the parent(s) or legal representative according to ICH/GCP, and national/local regulations.
- •FFPE tumor tissue from surgical resection and whole blood for central pathology review
- •Step 2: Enrollment/randomization
- •Newly diagnosed, histologically proven, genetically classified, centrally confirmed medulloblastoma (WNT M0-1, SHH (p53wt) M0-1, Group 4 M0-1)
- •Molecular subtype: medulloblastoma, SHH-activated and TP53-wildtype, M0-1; medulloblastoma, WNT-activated, M0-1; medulloblastoma, Group 4, M0-1
- •Histologic subtype: medulloblastoma, classic (CMB); medulloblastoma, desmoplastic/nodular (DNMB); medulloblastoma, with extensive nodularity (MBEN); medulloblastoma, large cell/anaplastic (LCA)
- •Adults (= 18 years) in WNT-activated and Group 4 medulloblastoma
- •Post-pubertal patients (<18y of age), or adults (18 y of age and above) in SHH-activated and TP53-wildtype medulloblastoma
- •Patients (<18 years) must have completed puberty
- •Patients (<18 years) must have a radiologically confirmed bone age of minimum 15 years for females and 17 years for males
- •Non-SHH dependent patients under age 18 should be transferred to a paediatric site for inclusion in the PNET5 trial in countries where PNET5 is open. SHH-activated patients under age 18 with M1 disease or above should be transferred to a paediatric site for inclusion in the HRMB trial in countries where HRMB is open.
- •Clinical status within 2 weeks of randomization/enrollment: Karnofsky 50-100. NANO-score 0 to 9 (allowing full-blown cerebellar symptoms)
- •Clinically standard-risk (centrally assessed MRI review) defined as: total or near total surgical resection with less than or equal to 1.5 cm2 (measured in axial plane) of residual tumour on early post-operative MRI, without and with contrast; no CNS metastasis on MRI (cranial and spinal); Chang stage M0-1 with no clinical evidence of extra-CNS metastasis
- •Full recovery from surgery or any post-surgical complication (e.g. bleeding, infections etc.)
- •Post-surgery (within 72h) MRI available (pre-surgery MRI upload is encouraged if available)
- •Baseline brain MRI and spinal MRI for uploading available within 2 weeks of randomization/enrollment
- •Normal liver, renal and haematological function within 2 weeks of randomization/enrollment.
- •WBC = 3×10^9/L
- •ANC = 1.5×10^9/L
- •Platelet count of = 100×10^9/L independent of transfusion
- •Hemoglobin = 10 g/dl
- •Total Bilirubin = 1.5 × ULN
- •ALT (SGPT), AST (SGOT), alkaline phosphatase (ALP) = 2.5 × ULN
- •Serum creatinine < 1.5 × ULN or creatinine clearance (CrCl) >60 ml/min (using the MDRD formula)
- •According to CTFG recommendations related to contraception and pregnancy testing during clinical trials, a negative serum or urine pregnancy test within 7 days before randomization/enrollment for WOCBP
- •Patients of childbearing / reproductive potential (WOCBP) must use two methods of adequate birth control, including a highly effective method and a barrier method during the study treatment period and for at least 20 months after the last study treatment is mandatory for the patients that received sonidegib, for all other patients this period is at least 12 months after the last study treatment. A highly effective method of birth control is defined as tho
排除标准
- •Step 2: Enrollment/randomization
- •Prior treatment for medulloblastoma
- •Unavailability of central review pathology results
- •Known prognostic markers (MYC/MYCN amplification, MYC/MYCN mutation)
- •Exclusion of germline alterations prognostically linked to medulloblastoma (e.g., TP53, PTCH, SUFU, BRCA2, PALB2), if known before randomization
- •Inability to start radiotherapy within 43 days after surgery
- •Significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing impairment = 20 dB at 1-3 kHz
- •Any medical contraindication to radiotherapy or chemotherapy
- •Hypersensitivity to contrast medium for MRI
- •Hypersensitivity towards the active substance of any of study drugs or their excipients
- •Prior or current use of mitoxantrone, methotrexate, topotecan, imatinib, irinotecan or statins
- •Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
- •Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical carcinoma in situ, low risk prostate cancer (cT1-2a N0 and Gleason score = 6 and PSA < 10 ng/mL), either totally resected or irradiated with curative intent (with PSA of less than or equal to 0.1 ng/mL) or under active surveillance as per ESMO guidelines. Other cancers for which the subject has completed potentially curative treatment more than 5 years prior to diagnosis of medulloblastoma study entry are allowed
- •Known history or current evidence of active Hepatitis B (e.g., positive HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected)
- •Known or current evidence of Human Immunodeficiency Virus (HIV) infection (positive HIV-1/2 antibodies)
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •All eligibility criteria must be adhered to. A deviation of 5% for hematological and 10% for biochemistry values will be acceptable.
- •The randomization/enrollment process can start after central pathology results are available.
- •Treatment must start within 14 days of randomization/enrollment BUT the latest on day 43 after surgery.
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