JPRN-jRCTs051180206招募中2 期
Phase II study of VAC1.2(vincristine, actinomycin-D, cyclophosphamide) followed by VA for patients with newly diagnosed low-risk subset A rhabdomyosarcoma. - JRS-II LRA
Tsuchiya Kunihiko0 个研究点目标入组 22 人开始时间: 2019年3月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
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
- ot applicable 至 < 30age old（—）
- 性别
- All
入选标准
- •1) Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), meeting criteria for low-risk subset A.
- •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.
排除标准
- •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
研究者
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