JPRN-jRCTs031180003进行中（未招募）2 期
JCOG1306:Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma ( AI vs GD for STS RPII/III ) - AI vs GD for STS RPII/III
Ozaki Toshifumi0 个研究点目标入组 140 人开始时间: 2019年1月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma (NRC-STS) with histology of undifferentiated pleomorphic sarcoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, angiosarcoma, malignant peripheral nerve sheath tumor or undifferentiated sarcoma (WHO classification) using open biopsy specimen
- •2) Primary tumor or first local recurrent tumor
- •3) 10 or more unstained tumor tissue slides are available
- •4) UICC/AJCC TNM (7th edition): T2bN0M0 or any TN1M0 (in case of primary tumor)
- •5) No distant metastases (in case of first local recurrent tumor)
- •6) Tumor in the extremities or trunk
- •7) Having measurable lesion on MRI axial section
- •8) Resectable with appropriate margins
- •9) Age >= 20 and =< 70
- •10) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •11) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS
- •12) Sufficient organ function
- •13) No abnormal ECG findings
- •14) Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding
- •15) Written informed consent.
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
- •2) Active infection requiring systemic therapy
- •3) Body temperature >= 38 degrees Celsius
- •4) Women in pregnant, possibly pregnant or breast feeding
- •5) Psychiatric disease
- •6) Patients requiring systemic steroid medication
- •7) Unstable angina within 3 weeks, or with a history of myocardial infarction
- •8) Poorly controlled hypertension
- •9) Poorly controlled diabetes mellitus or routine administration of insulin
- •10) Positive HBs antigen
研究者
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