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临床试验/JPRN-UMIN000007190
JPRN-UMIN000007190已完成2 期

Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer - PHOENiX trial

Epidemiological and Clinical research Information Network (ECRIN)0 个研究点目标入组 45 人开始时间: 2012年2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
45

研究概览

简要总结

RESULTS: A total of 51 patients were enrolled from 14 institutions from December 2011 to July 2012. The median age was 66 (range=38-85) years, 29 (56.9%) had colonic cancer and 22 (43.1%) had rectal cancer in this study. Pertinent grade 3/4 toxicities were neutropenia (13.7%), peripheral neuropathy (13.7%), hypertension (13.7%), gastrointestinal perforation (3.9%), and hand-foot syndrome (5.9%). The response rate was 51% (one complete and 25 partial responses). Median PFS and TTP were 344 days and 196 days, respectively. Median overall survival has not been reached yet.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Serious renal dysfunction 2. Serious drug hypersensitivity or a history of drug allergy 3. Active multiple primary neoplasm 4. Active infections 5. Serious heart disease 6. History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 7. Fresh gastrointestinal hemorrhage, intestinal obstruction or peptic ulcer 8. Pleural effusion, peritoneal fluid and pericardial fluid 9. Symptomatic brain metastasis 10. History of mental disturbances or cerebrovascular disorder 11. Uncontrolled high blood pressure and diabetes 12. Uncontrolled diarrhea 13. Serious non-healing wound and/or major surgical procedure within 4 weeks prior to enrollment 14. Traumatic fracture not healed 15. Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) 16. Pregnant or possibly pregnant, and nursing women 17. Peripheral neuropathy 18. Other conditions not suitable for this study

研究者

发起方
Epidemiological and Clinical research Information Network (ECRIN)

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