JPRN-UMIN000000638已完成2 期
Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer (OGSG 0402) - OGSG0402
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)0 个研究点目标入组 102 人开始时间: 2007年4月1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
- 102
研究概览
简要总结
The overall response rate (ORR) was determined by the RECIST criteria as, 33.3% (95% Confidence Interval, CI=20.3-47.9) for S-1 plus irinotecan (n=51) compared to 31.4% (95% CI=19.1-45.9) for S-1 plus paclitaxel (n=51), with no statistically significant difference (p=0.841). PFS was 173 days for S-1 plus irinotecan compared with 141 days for S-1 plus paclitaxel (HR=1.18, p=0.421). The median survival time (MST) was 379 days for S-1 plus irinotecan and 364 days for S-1 plus paclitaxel (HR=0.988, p=0.956) .
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) active double cancer 2) with other severe diseases (ileus, interstitial pneumonia/pulmonary fibrosis, cardiac failure, renal dysfunction, liver dysfunction) 3) with infectious diseases 4) under condition of diarrhea 5) with marked chest or abdominal fluid 6) history of allergy against medicine 7) receiving fluoropyrimidine, antifungal flusitosine or Atazanabil sulfate 8) with gastrointestinal bleeding which needs blood transfusion 9) with liver cirrhosis or jaundice 10) with psychiatric disease which needs medicine 11) with cardiac disease which needs therapy 12) with uncontrolled D M 13) with metastasis to the central nerve system 14) under pregnancy or nursing the baby 15) excluded by doctor due to the other reasons
研究者
相似试验
招募中
不适用
Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type (OGSG 0901)advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild typeJPRN-UMIN000002695Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)35
已完成
2 期
A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancerChemotherapy-naïve metastatic gastric cancerJPRN-C000000104Hiroshima Cancer Therapy Development Organization (HiCTDO)130
招募中
2 期
Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutatioColorectal cancerJPRN-UMIN000014892iigata Colorectal Cancer Study Group50
已完成
2 期
Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.gastric cancerJPRN-UMIN000028329ational Cancer Center Hospital East20
已完成
不适用
Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric CancerInoperable or Recurrent Gastric CancerJPRN-UMIN000003156Hiroshima University Hospital90