An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Phase III, Randomized, Controlled Study Comparing the Efficacy and Safety of mFOLFOX6 + Bevacizumab Therapy vs. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Wild-type RAS(KRAS/NRAS) Unresectable Advanced or Recurrent Colorectal Cancer
An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Phase III, Randomized, Controlled Study Comparing the Efficacy and Safety of mFOLFOX6 + Bevacizumab Therapy vs. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Wild-type RAS(KRAS/NRAS) Unresectable Advanced or Recurrent Colorectal Cancer
The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.
The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.
Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.
Inclusion Criteria:
(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
Exclusion Criteria:
(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study
Kounan, Aichi-ken, Japan
Yoshida, Fukui, Japan
Okazai, Gifu, Japan
Kida, Kagawa-ken, Japan
Matsuzaka, Mie-ken, Japan
Yamatotakada, Nara, Japan
Kitaadachi, Saitama, Japan
Izumi, Shimane, Japan
Sunto, Shizuoka, Japan
Shimotsuga, Tochigi, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjyuku-ku, Tokyo, Japan