ACTRN12610000509066已完成3 期
A phase III clinical trial comparing disease free survival between the combination of capecitabine and oxaliplatin (XELOX) versus the combination of fluorouracil (5FU)/leucovorin (LV) and oxaliplatin (FOLFOX) as an adjuvant therapy in patients with operated colorectal cancer of stages B2 (high risk) and C (according to Duke's)
Hellenic Cooperative Oncology Group0 个研究点目标入组 824 人开始时间: 2010年6月21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
- 824
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Signed written informed consent on the trial relevant procedures
- •2. Histologically confirmed colon adenocarcinoma according to the International Organization Against Cancer (UICC) classification. The tumor must be radically excised. The patients must be histologically in a B2 (high risk) or C stage according to Duke’s. Stage B2 high risk includes: patients with poorly differenciated or mucous tumors, stage T4 tumors, outer-wall vein invasion, obstruction or perforation
- •3. During surgery at least eight (8) regional lymph nodes should be obtained
- •4. Absence of any metastatic or residual disease after surgery
- •5. Enrollment after 4 to 6 weeks after surgery
- •6. Age of >18 and <75 years
- •7. Performance status (according to Eastern Cooperative Oncology Group) <2
- •8. Satisfactory hematological profile, liver and renal function (within 14 days before the beginning of chemotherapy) that are described as follows:
- •- Hematological profile:
- •i. Neutrophils > 2.0x10^9 /L
- •ii. Platelets > 150x10^9 /L
- •iii.Hemoglobin > 10 g/dL
- •- Liver function tests:
- •i. Total bilirubin up to the upper normal limit
- •ii. Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) up to 2.5 times the upper normal limit
- •iii. Alkaline phosphatase up to 2.5 times the upper normal limit
- •- Renal function tests:
- •i. Creatinine up to 1.5 times the upper normal limitii. If the creatinine value is higher, the estimated creatinine clearance should be higher than 60 ml/hour
- •9.Negative pregnancy test (for women of reproductive age)
排除标准
- •1. Patients with simultaneous metastasis from the primary tumor that has been totally excised
- •2. Concomitant therapy with other investigational products 3. Patients that have received previous anticancer therapy 4. Patients that cannot be monitored adequately due to psychological, social, geographic, economic or family reasons
- •5. Patients who clearly state that they want to enroll in a particular arm of the trial
- •6. Simultaneous serious disease that affects the participation in the trial
- •7. Psychiatric or other disorders that do not permit obtaining the informed consent and compliance of the patient to the schedule of the evaluation visits
- •8. Patients of reproductive age who refuse to take adequate contraceptive measures during the therapy
- •9. Prior or current history of: chronic diarrhea, inflammatory bowel disease, active peptic ulcer or intestinal bleeding
- •10. Hypersensitivity to oxaliplatin, capecitabine or to fluoropyrimidines
- •11. Recent history (last 6 months) of cardiac infarction, coronary disease, serious congestive heart failure, uncontrolled hypertension, non-controlled arrythmias
- •12. History of other neoplasm with the exception of in situ cervical carcinoma or non-melanoma skin cancer
研究者
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