JPRN-UMIN000008866已完成3 期
Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT) - Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)
Japan Clinical Oncology Group (JCOG)0 个研究点目标入组 250 人开始时间: 2012年9月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- 70years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I. 2) Infectious disease to be treated. 3) Body temparature >= 38c 4) Severe mental disease. 5) Currently treated with systemic steroids 6) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 7) Uncontrollable diabetes mellitus or routine administration of insulin. 8) New York Heart Association (NYHA) class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias. 9) Positive for HBsAg 10) Inadequately controlled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg on anti-hypertensive medications. 11) History of unstable angina, myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral hemorrhage, cerebral infarction, transient ischemic attack (TIA), cerebrovascular disturbance, or arterial thromboembolism. 12) Known hypersensitivity to any of the component of 5-FU/LV, capecitabine, oxaliplatin, or bevacizumab. 13) Inadequate characteristics for bevacizumab administration.
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