Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed low-risk subset B rhabdomyosarcoma. - JRS-II LRB

Miyachi Mitsuru0 个研究点目标入组 18 人开始时间: 2019年3月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), meeting criteria for low-risk subset B.
•2) Age younger than 30 years old.
•3) Initiation of chemotherapy within 42 days after pathological diagnosis.
•4) No prior history of malignancy.
•5) ECOG 0-2 (>=16 years old) or Lansky 50-100% (< 16 years old)
•6) Patients must have sufficient organ function.
•7) All patients and/or their parents or legal guardians must sign a written informed consent.

•1) patients with primary tumor of CNS origin, CNS metastasis or positive CSF cytology
•2) patients with synchronous or metachronous concomitant malignancies
•3) patients with Charcot-Marie-Tooth disease or varicella
•4) prior history of chemotherapy or radiation therapy
•5) patients with uncontrollable complications
•Interstitial pneumonia, pulmonary fibrosis, severe emphysema
•Uncontrollable diabetes mellitus
•Uncontrollable hypertension
•Severe electrocardiogram abnormality or clinically significant heart disease(heart failure, myocardial infarction, angina pectoris)
•Liver failure, cirrhosis
•Renal failure
•6) patients with contraindication of drugs used in this study
•7) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy
•8) Patients with any other inappropriate condition judged by physician

发起方

Miyachi Mitsuru