JPRN-jRCTs031200107招募中2 期
A safety / efficacy trial of isotretinoin as a maintenance therapy for newly diagnosed high risk neuroblastoma
Makimoto Atsushi0 个研究点目标入组 25 人开始时间: 2020年9月3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
- 25
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
- >= 1age old 至 < 18age old(—)
- 性别
- All
入选标准
- •1. Aged between 1 and 18
- •2. Histopathological diagnosis with neuroblastoma or ganglioneuroblastoma
- •3. Stratified to high risk group according to International Neuroblastoma Risk Grouping System
- •4. No progression after primary treatment including chemotherapy, high-dose chemotherapy with hematopoietic stem cell transplantation and radiotherapy
- •5. Within 84 days after the most recent hematopoietic stem cell transplantation or the last day of post-transplantation therapy
- •6. No severe organ damage to disturb protocol treatment
- •7. No active infectious disease
- •8. Written informed consent from the patient and/or the guardian
排除标准
- •1. During an active anticancer treatment or planning anticancer treatment except for immunotherapy including dinutuximab
- •2. Concomitant malignancy
- •3. Allergy to gelatin
- •4. Female patient in pregnancy or possible pregnancy, or during breast feeding
- •5. Concomitant psychiatric disorders
- •6. Complications which would be an obstacle to observe the treatment protocol
研究者
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