A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

The Tokyo Cooperative Oncology Group0 个研究点目标入组 450 人开始时间: 2012年5月11日最近更新: 2023年10月17日

试验速览

暂无简介。

•1.Histologically proven colorectal cancer (Adenocarcinoma)
•2.Unresectable advanced/recurrent colorectal cancer
•3.Aged over 20 years at the time of registration
•4.Performance status(ECOG) :0,1
•5.Patients with evaluable lesion
•6.Previously not treated (chemotherapy, radiotherapy, etc.) for unresectable colorectal cancer
•7.Able to receive oral treatment
•8.Adequate organ function
•9.Life expectancy estimated>=3 months
•10.Written IC

•1.History of serious drug hypersensitivity
•2.Pregnant, lactating or women of
•child-bearing potential. Men who want get partner pregnant.
•3.Active infections
•4.Serious complications
•5.Significant abnormal ECG or history of cardiovascular disease
•6.Peptic ulcers
•7.Peripheral neuropathy
•8.Watery diarrhea
•9.Massive pleural effusion or ascites
•10.Mechanical bowel obstruction
•11.Symptomatic peritoneum dissemination
•12.Brain metastasis
•13.Current or previous (within the last 6 months) history of GI perforation
•14.Hemoptysis (=> 2.5ml)
•15.Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
•16.Any surgical treatments within 28 days
•17.Evidence of bleeding diathesis or coagulopathy
•18.Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
•19.Administering transfusion within 14 days
•20.Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
•21.Under coutinuous steroid administration
•22.Active hepatitis type HBs positive
•23.Administration contraindication of 5-FU, Leucovorin, Capecitabine, TS-1, Oxaliplatin, CPT-11 and Bevacizumab
•24.Any other cases who are regarded as inadequate for study enrollment by the investigator

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