KCT0004525招募中未知
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) who Received Radical Resection
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 76(Year)（—）
- 性别
- All
入选标准
- •1. Patients who voluntarily provide written informed consent prior to entering into this study
- •2. Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- •3. Patients who underwent radical resection (R0 resection) with wide lymph node dissection (D2 surgery)
- •4. TNM stage of IIIB or IV (M0) on post-operative staging (based on AJCC Ed. 6)
- •5. Patients who can be randomized within 6 weeks after surgery
排除标准
- •1. Aged < 20 years or = 76 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status =2
- •3. Patients who underwent surgery for neoplasm in stomach in the past
- •4. History of malignant disease
- •The following cases can be included in this study.
- •- Adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- •- Other cancer for which more than 5 years have passed since chemotherapy was completed and disease-free status has been maintained for 5 years or more
- •5. Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
- •6. Residual cancer on post-operative staging (R1 and R2 resection)
- •7. Patients who received alleviator, adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- •8. Patients who participated in another clinical trial or received another investigational product within 30 days prior to providing informed consent
- •9. Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment.
- •10. Patients with past uncontrolled seizures, central nervous system or psychological disorder which makes it impossible to provide informed consent and is so clinically significant as to interfere with oral medication
- •11. Uncontrolled active infection or sepsis
- •12. Deep vein thrombosis within 4 weeks prior to providing informed consent
- •13. Severe acute or chronic disease which may deteriorate the capability to participate in the study or make it difficult to interpret the study results
- •14. Not fully recovered from surgery
- •15. Patients who may have difficulty in absorbing orally administered study drug
- •- Intolerance to oral administration or malabsorption
- •- Lack of physical integrity of upper gastrointestinal tract is not recovered
- •- Absorption disorder for any reason
- •- Chronic inflammatory bowel disease
- •- Wide resection of small intestine or other disease limiting drug absorption (e.g., gastric dumping syndrome, features of rapid small bowel transit time, absorption disorder after intestine surgery)
- •16. Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
- •17. Pregnant women or breastfeeding women. Women of childbearing potential whose pregnancy test result is positive
- •18. Bone marrow and organ function inappropriate for administration of study drug:
- •I. Absolute neutrophil count < 1.5 x 109/L
- •II. Platelet < 100 x 109/L
- •III. Hemoglobin = 9 g/dL
- •IV. AST> 2.5 x ULN, ALT> 2.5 x ULN
- •V. ALP > 2.5 x ULN
- •VI. Total bilirubin > 1.5 x ULN
- •VII. Serum creatinine > 1.5 x ULN or creatinine clearance = 50 mL/min
- •Creatinine clearance will be calculated by Cockcroft-Gault formula or collection of 24-hour urine, and patients with creatinine clearance of = 50 mL/min will be excluded.
- •19. Peripheral neuropathy with clinical symptoms of Grade =2 (NCI CTCAE v4.03)
- •20. History of hypersensitivity to the investigational products (Docetaxel, Capecitabine, and Oxaliplatin).
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