Phase II study to evaluate the efficacy and safety of the multimodality therapy for atypical teratoid rhabdoid tumors with the intensified chemotherapy via intrathecal therapy and subsequent high-dose chemotherapy comprising thiotepa and melphalan and following delayed irradiation - JCCG AT20

Junichi Hara0 个研究点目标入组 50 人开始时间: 2020年10月22日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Locally diagnosed as atypical teratoid rhabdoid tumor (ATRT) after tumor resection or biopsy.
•2) Registered in an observational study for pediatric solid tumors by Japan Children's Oncology Group (JCCG).
•3) A sample for a central diagnosis has been submitted or is scheduled to be submitted.
•4) Protocol treatment can be started within 6 weeks after surgery
•5) Less than 21 years
•6) No prior radiation therapy or chemotherapy
•7) ECOG Performance Status (PS) is 3 or less
•8) The following conditions are met within 14 days prior to registration
•1. WBC>=2000/maicroL
•2. PLT>=100,000/maicroL
•3. AST<=100IU/L
•4. D-Bil<=1.0mg/dl
•5. Serum creatinine level is below the upper limit of normal value
•9) Written informed consent is obtained from the patient or his/her legal guardian.

•1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less).
•2) Presence of extracranial metastasis (M4) or extracranial rhabdoid tumor.
•3) Complicated heart disease requiring treatment.
•4) You are pregnant or nursing.
•5) Ddeemed inappropriate at the discretion of the attending physician.

发起方

Junichi Hara