JPRN-jRCTs041180118已完成2 期
Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant - INSPIRE
Mishima Hideyuki0 个研究点目标入组 50 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
First-line chemotherapy with re-introduction of Oxaliplatin more than six months after adjuvant chemotherapy including Oxaliplatin can be used safely with expected efficacy for relapsed colon cancer patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Stage II, III colon cancer patients treated with oxaliplatin based adjuvant chemotherapy. 2)Recurrence after more than 6 months post adjuvant chemotherapy
- •3)Peripheral neuropathy<=grade1
- •4)Cumulative dose of oxaliplatin >=more than 300 mg/m2 as adjuvant therapy
- •5)Measurable lesion by RECIST1.1
- •6)Age of 20 years or older
- •7)ECOG Performance status(PS) of 0-1
- •8)A life expectancy of more than 12 week.
- •9)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.),
- •laboratory data within 14 days
- •WBC <=12,000mm3
- •neutrophil >=1,500/mm3
- •hemoglobin >=8.0g/dL
- •platelet >=100,000/mm3
- •AST and ALT
- •<=2.5 ULN or <=5.0 ULN if the patient has liver metastasis
- •T-Bil <=1.5 ULN
- •Creatinine clearance >=50 mL/min 10)Written informed consent.
排除标准
- •1)Serious drug allergy.
- •2)Serious sensory abnormality or dysfunction
- •3)Presence of other active malignancies or a history of malignancies within the past 5 years
- •4)blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days .
- •5)Uncontrolled pleural effusion, ascites, or pericardial effusion.
- •6)Clinically significant infection.
- •7)brain metastasis
- •8)Clinically significant heart disease (myocardial infarction within 12 months, etc.).
- •9)Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure )
- •10)fresh GI bleeding
- •11)Watery diarrhea
- •12)Central nervous system disorders
- •13)Dementia or clinically significant mental/neurological disorders.
- •14)Women who are pregnant, lactating, or wish to become pregnant.
- •15)Investigator's judgement.
研究者
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