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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.
Age
20 - 79 years
Sex
ALL
Healthy Volunteers
No
Ichinomiya, Aichi-ken, Japan
Komaki, Aichi-ken, Japan
Kounan, Aichi-ken, Japan
Nagakute, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Toyokawa, Aichi-ken, Japan
Toyota, Aichi-ken, Japan
Yatomi, Aichi-ken, Japan
Start Date
May 29, 2015
Primary Completion Date
March 31, 2026
Completion Date
March 31, 2026
Last Updated
May 9, 2025
757
ACTUAL participants
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab
DRUG
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
DRUG
Lead Sponsor
Takeda
NCT04704661
NCT06696768
Data Source & Attribution
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