Protocol of a randomised phase III clinical trial of sequential capecitabine or 5-fluorouracil plus bevacizumab (Cape/5-FU-Bmab) to capecitabine or 5-fluorouracil plus oxaliplatin plus bevacizumab (CapeOX/mFOLFOX6- Bmab) versus combination CapeOX/ mFOLFOX6-Bmab in advanced colorectal cancer: the C-cubed (C) study
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چکیده
Takeshi Nagasaka, Hideyuki Mishima, Akira Sawaki, Mototsugu Shimokawa, Michio Inukai, Katsunori Shinozaki, Hiroaki Tanioka, Junichiro Nasu, Tomohiro Nishina, Shoichi Hazama, Masazumi Okajima, Yoshiyuki Yamaguchi To cite: Nagasaka T, Mishima H, Sawaki A, et al. Protocol of a randomised phase III clinical trial of sequential capecitabine or 5fluorouracil plus bevacizumab (Cape/5-FU-Bmab) to capecitabine or 5-fluorouracil plus oxaliplatin plus bevacizumab (CapeOX/ mFOLFOX6-Bmab) versus combination CapeOX/ mFOLFOX6-Bmab in advanced colorectal cancer: the C-cubed (C) study. BMJ Open 2016;6:e011454. doi:10.1136/bmjopen-2016011454
منابع مشابه
Protocol of a randomised phase III clinical trial of sequential capecitabine or 5-fluorouracil plus bevacizumab (Cape/5-FU-Bmab) to capecitabine or 5-fluorouracil plus oxaliplatin plus bevacizumab (CapeOX/mFOLFOX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer: the C-cubed (C3) study
INTRODUCTION Results from several randomised trials suggest that the sequential use of cytotoxic agents in patients with metastatic colorectal cancer (mCRC) has the potential to improve overall survival compared with combination chemotherapy. This study is designed to investigate whether sequential treatment with bevacizumab-based first-line treatment with oxaliplatin is superior to combination...
متن کاملSafety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study.
PURPOSE To evaluate the safety and efficacy of three oxaliplatin and fluoropyrimidine regimens, with or without bevacizumab, as first-line treatment for metastatic colorectal cancer (CRC). PATIENTS AND METHODS Patients with histologically documented metastatic or recurrent CRC and no prior treatment for advanced disease were randomly assigned to mFOLFOX6 (bolus and infusion fluorouracil [FU] ...
متن کاملS-1 and oxaliplatin (SOX) plus bevacizumab versus mFOLFOX6 plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer: updated overall survival analyses of the open-label, non-inferiority, randomised phase III: SOFT study
OBJECTIVE The SOFT study previously demonstrated that S-1 and oxaliplatin (SOX) plus bevacizumab was non-inferior to l-leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) plus bevacizumab in terms of the primary end point of progression-free survival (PFS) as first-line chemotherapy for metastatic colorectal cancer (mCRC). The overall survival (OS) data were immature at the time of the primary ...
متن کاملComparison between three oxaliplatin-based regimens with bevacizumab in patients with metastatic colorectal cancer
BACKGROUND A previous pivotal Phase III study (NO16966) demonstrated the benefit of the addition of bevacizumab (BV) to oxaliplatin-based regimens in metastatic colorectal cancer (MCRC). Our study evaluated the safety and efficacy of three oxaliplatin-based chemotherapy regimens (FOLFOX4 [intravenous twice-bolus and twice-infusional 5-fluorouracil/folinic acid plus oxaliplatin], mFOLFOX6 [intra...
متن کامل5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study
BACKGROUND Sunitinib is an oral inhibitor of tyrosine kinase receptors implicated in tumor proliferation, angiogenesis, and metastasis. In this randomized, multicenter, open-label Phase IIb study, sunitinib plus mFOLFOX6 (oxaliplatin plus leucovorin plus 5-fluorouracil) was compared with bevacizumab plus mFOLFOX6 as first-line therapy in patients with metastatic colorectal cancer. METHODS Pat...
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