JPRN-jRCTs031180126进行中（未招募）3 期
JCOG0905: A Phase III Study Comparing Methotrexate, Adrimycin and Cisplatin (MAP) with MAP + Ifosfamide (MAP + IF) for the Treatment of Osteosarcoma - OS-MAP + IF-P3
HIRAGA Hiroaki0 个研究点目标入组 250 人开始时间: 2019年2月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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 <= 50age old（—）
- 性别
- All
入选标准
- •1) Histologically and Radiologically confirmed high grade osteosarcoma.
- •2) Ten or more slides of biopsy specimen available for central pathological review.
- •3) Tumor located in upper/lower extremity/sternum/rib.
- •4) Resectable tumor.
- •5) Stage IIA, IIB, or III of 6th Edition TNM-UICC classification.
- •6) No previous history of osteosarcoma.
- •7) No previous history of chemotherapy and radiotherapy for any cancers.
- •8) No definite findings of familial tumors.
- •9) Aged 50 years old or less.
- •10) Performance Status (ECOG): 0 or 1.
- •11) Sufficient organ functions.
- •12) Written informed consent.
排除标准
- •1) Uncontrollable diabetes mellitus.
- •2) Uncontrollable hypertension.
- •3) History of myocardial infarction or attack of unstable angina pectoris.
- •4) Using artificial cardiac pacemaker.
- •5) Active infection.
- •6) Fever over 38 degrees centigrade.
- •7) Simultaneous or metachronous (within the past 5 years) double cancers.
- •8) Women during pregnancy or breast-feeding.
- •9) Women within 28 days after delivery or women 29 days or more after delivery without uterine subinvolution confirmed by an obstetrician.
- •10) Psychiatric disease or symptom.
- •11) Systemic steroids medication.
- •12) Positive for HBs antigen, HBc antibody, or HBs antibody.
研究者
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