JPRN-UMIN000007004已完成未知
A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy + oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer (OGSG 1107) - A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy+oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)0 个研究点目标入组 19 人开始时间: 2012年1月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
The median 1st PFS and 2nd PFS were 12.8 months (95% confidence interval {CI] 10.4-26.7) and 19.1 months (95% CI 16.1-not reached [NR] months), respectively. The median 1st PFS C-group (Capecitabine + bevacizumab): 17.2 months (95% CI: 11.1 - NR) S-group (S-1 + bevacizumab): 10.8 months (95% CI: 10.4 - NR) F-group(LV/5-FU + bevacizumab): 11.2 months (95% CI: 7.8 - NR)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)with symptoms due to brain metastasis 2)with uncontrollable diarrhea 3)with difficulty on oral intake due to intestinal paralysis or obstruction 4)with infectious disease or febrile condition 5)HBs Ag (+) 6)with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.) 7)with severe diseases (uncontrollable DM, heart failure severe than NYHA III, renal failure and/or hepatic failure) 8)pregnant and/or nursing women, or women who expect pregnancy 9)with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 10)with a more than grade 1 neural disorder 11)with a condition intolerant to medicines in this regimen (5-FU, Xeloda, TS-1, Avastine or Erplat) 12)with a history of allergy against 5-Fu, Capecitabine or TS-1 13)with a history of some chemotherapy and/or therapy including a VEGF antagonist for unresectable advanced/recurrent colon cancer 14)with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction 15)under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 16)with a history of thoracic surgery or abdominal surgery 28 days ago except reservoir surgery 17)with active wounds 18)with a history of bloody spit more than 2.5mL 19)any other patient whom the physician in charge of the study judges to be unsuitable
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