A Randomized Phase III Trial of S-1/Oxaliplatin (SOX) plus Bevacizumab versus 5-FU/l-LV/Oxaliplatin (FOLFOX) plus Bevacizmab in Treating Patients with Metastatic Colorectal Cancer.

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 500 人开始时间: 2009年2月12日最近更新: 2023年10月17日

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•Histologically confirmed colorectal adenocarcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
•- Age:20-79 years
•- ECOG Performance status:0-1
•- Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
•- No prior chemotherapy or radiotherapy(Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment)
•- Adequate oral intake
•- Adequate function of major organs
•- Life expectancy of at least 3 months
•- Voluntary written informed consent

•- Serious drug hypersensitivity or a history of drug allergy
•- Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
•- Active infections (e.g., patients with pyrexia of 38 degrees C or higher)
•- Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension)
•- Remarkable electrocardiographic abnormality, or cardiac disease (cardiac failure, cardiac infarction, and angina pectoris)
•- Gastrointestinal ulcer or bleeding
•- Peripheral sensory neuropathy
•- Serious diarrhea
•- Ascites or pleural effusion requiring treatment
•- Brain metastasis
•- History of gastrointestinal perforation within 6 months
•- History of thrombo-embolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
•- Major surgical procedure within 4 weeks
•- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
•- Concurrent treatment with anti-coagulation drug
•- Active double cancer
•- Prior treatment with oxaliplatin as adjuvant chemotherapy
•- Continuous treatment with steroids
•- Judged ineligible for participation in the study by the investigator
•- Case who has primary lesion with severe stenosis that endoscope doesn't pass(e.g., primary resection or colostomy)
•- Case who has peritoneum metastasis that can be confirmed by image

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