JPRN-jRCTs031190152进行中（未招募）2 期
JCOG1802: A randomized phase II trial of 2nd line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin and pazopanib - 2ND-STEP
TANAKA Kazuhiro0 个研究点目标入组 120 人开始时间: 2019年12月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Histologically proven soft tissue sarcoma
- •(2) H&E slides used for diagnosis of (1) are available
- •(3) Soft tissue sarcoma with metastatic disease (Stage IV in AJCC- TNM 8th edition), unresectable primary sarcoma, or unresectable recurrent sarcoma
- •(4) Disease progression confirmed within 6 months
- •(5) Disease to fulfill either following (i)-(iv), chemotherapy including perioperative chemotherapy
- •(i) Disease progression (local progression or metaetatsis) after chemotherapy including doxorubicin
- •(ii) Disease progression after termination of chemotherapy including doxorubicin because of other than disease progression
- •(iii) Reccurence of disease which is disappeared by chemotherapy including doxorubicin (local and distant recurrence)
- •(iv) Disease progression of residual disease after chemotherapy including doxorubicin
- •(6) History of chemotherapy for sarcoma is only regimen including doxorubicin
- •(7) No treatment history for sarcoma and other cancers with trabectedin, eribulin or pazopanib
- •(8) Age 16 years or older
- •(9)ECOG status (PS): 0-2
- •(10) Measurable or non-measurable disease
- •(11) Adequate oral intake
- •(12)Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration
- •[1] Nutrophil count>=1,500 /mm3
- •[2] Hemoglobin>=8.0 g/dL
- •[3] Platelet count>=100,000 /mm3
- •[4] Total bilirubin<=1.5 mg/dL
- •[5] AST<=100 U/L
- •[6] ALT<=100 U/L
- •[7] Renal function to fulfill either following (a) or (b),
- •(a) Creatinine<=1.5 mg/dL
- •(b) Creatinine clearance>=50 mL/min
- •[8] ALP<=900 U/L (JSCC method), ALP<=315 U/L (IFCC method)
- •[9] CPK,=600 U/L for men, <=400 U/L for woman
- •[10] PT-INR<=1.38
- •[11] APTT<=44.4 sec
- •[12] TSH: 0.5-4.5 micro U/mL
- •[13] FT4: 0.9-1.8 ng/dL
- •(13) Normal findings or no need of treatment in case of abnormal findings on electrocardiogram (ECG) within 28 days prior to registration
- •(14) Ejection fraction of cardiac ultrasound examination: more than 50% within 28 days prior to registration
- •(15) Written informed consent (If the patient's age is under 20 years old, the additional consent must be obtained from the patient's parent or legal guardian.)
排除标准
- •(1) Synchronous or metachronous (within 2 years) malignancy except cancer with 2-year relative survival rate of 95% or more
- •(2) Diagnosed with active infectious disease requiring systemic treatment
- •(3) Febrile more than 38 degrees Celsius at the registation
- •(4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. Male subjects who want pregnancy of their partner
- •(5) Psychological disorder difficult to participate in this clinical study
- •(6) Receiving continuous systemic corticosteroid or immunesuppressant treatment (systemically or intravenously)
- •(7)Systolic blood pressure>140 mmHg and diastolic blood pressure>90 mmHg two consecutive times measured in a hospital on the day of registration (irrespective of antihypertensive agents use)
- •(8) Interstitial pneumonia , pulmonary fibrosis or severe emphysema based on chest CT
- •(9) HBs antigen positive
- •(10) History of cardiovascular disease
- •[1] Myocardial infarction within the last 6 months, unstable angina pectoris within the last 3 weeks
- •[2] Angioplasty surgery or stent implantation, or coronary artery bypass graft within 6 months
- •[3] Heart failure class III or IV accorging to NYHA
- •[4] Uncontrolled valve disease, dilative cardiomyopathy, or hypertrophic myocardiopathy
- •(11) Active bleeding
- •(12) Symptomatic brain metastasis or brain metastasis requiring treatment (screening of brain metastasis is not required for clinically unnecessary patients)
- •(13) Pleural effusion, ascitic fluid, pericardial effusion requiring drainage
研究者
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