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ACTIVE NOT RECRUITING
NCT02394834

An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

OBSERVATIONAL

Enrollment

757

Start Date

2015-05-29

Completion Date

2026-03-31

Last Updated

2025-05-09

Healthy Volunteers

No

Interventions

DRUG

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab

oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

DRUG

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab

oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Locations (151)

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

Daisen, Akita, Japan

Hirosaki, Aomori, Japan

Misawa, Aomori, Japan

Kashiwa, Chiba, Japan

Yachiyo, Chiba, Japan

Matsuyama, Ehime, Japan

Tōon, Ehime, Japan

Tsuruga, Fukui, Japan

Yoshida, Fukui, Japan

Kitakyushu, Fukuoka, Japan

Koga, Fukuoka, Japan

Koga, Fukuoka, Japan

Kurume, Fukuoka, Japan

Omuta, Fukuoka, Japan

Aizu-Wakamatsu, Fukushima, Japan

Iwaki, Fukushima, Japan

Kōriyama, Fukushima, Japan

Shirakawa, Fukushima, Japan

Hashima, Gifu, Japan

Kakamigahara, Gifu, Japan

Minokamo, Gifu, Japan

Okazai, Gifu, Japan

Ōgaki, Gifu, Japan

Maebashi, Gunma, Japan

Ōta, Gunma, Japan

Fukuyama, Hiroshima, Japan

Hakodate, Hokkaido, Japan

Kitami, Hokkaido, Japan

Kushiro, Hokkaido, Japan

Obihiro, Hokkaido, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Akashi, Hyōgo, Japan

Amagasaki, Hyōgo, Japan

Himeji, Hyōgo, Japan

Kobe, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Hitachi, Ibaraki, Japan

Kasama, Ibaraki, Japan

Ryūgasaki, Ibaraki, Japan

Tsuchiura, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Hakusan, Ishikawa-ken, Japan

Kaga, Ishikawa-ken, Japan

Kahoku, Ishikawa-ken, Japan

Kanazawa, Ishikawa-ken, Japan

Nanao, Ishikawa-ken, Japan

Morioka, Iwate, Japan

Kida, Kagawa-ken, Japan

Marugame, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Fujisawa, Kanagawa, Japan

Hiratsuka, Kanagawa, Japan

Isehara, Kanagawa, Japan

Kamakura, Kanagawa, Japan

Kanazawachō, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Nankoku, Kochi, Japan

Matsuzaka, Mie-ken, Japan

Tsu, Mie-ken, Japan

Yokkaichi, Mie-ken, Japan

Ishinomaki, Miyagi, Japan

Murata, Miyagi, Japan

Natori-shi, Miyagi, Japan

Ōsaki, Miyagi, Japan

Sendai, Miyagi, Japan

Matsumoto, Nagano, Japan

Saku, Nagano, Japan

Ōmura, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Ikoma, Nara, Japan

Tenri, Nara, Japan

Yamatotakada, Nara, Japan

Yufu, Oita Prefecture, Japan

Kurashiki, Okayama-ken, Japan

Naha, Okinawa, Japan

Tomigusuku, Okinawa, Japan

Urasoe, Okinawa, Japan

Hirakata, Osaka, Japan

Kawachi-Nagano, Osaka, Japan

Moriguchi, Osaka, Japan

Neyagawa, Osaka, Japan

Sayama, Osaka, Japan

Suita, Osaka, Japan

Takatsuki, Osaka, Japan

Kawagoe, Saitama, Japan

Kitaadachi, Saitama, Japan

Koshigaya, Saitama, Japan

Moriyama, Shiga, Japan

Ōtsu, Shiga, Japan

Izumi, Shimane, Japan

Izumo, Shimane, Japan

Hamamatsu, Shizuoka, Japan

Izunokuni, Shizuoka, Japan

Sunto, Shizuoka, Japan

Shimotsuga, Tochigi, Japan

Shimotsuke, Tochigi, Japan

Utsunomiya, Tochigi, Japan

Komatsushimachō, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Koto-ku, Tokyo, Japan

Machida, Tokyo, Japan

Minato-ku, Tokyo, Japan

Musashino, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjyuku-ku, Tokyo, Japan

Yonago, Tottori, Japan

Kurobe-shi, Toyama, Japan

Takaoka, Toyama, Japan

Sakata, Yamagata, Japan

Tsuruoka, Yamagata, Japan

Iwakuni, Yamaguchi, Japan

Kofu, Yamanashi, Japan

Akita, Japan

Aomori, Japan

Chiba, Japan

Fukui, Japan

Fukuoka, Japan

Gifu, Japan

Kagoshima, Japan

Kochi, Japan

Kumamoto, Japan

Kyoto, Japan

Miyazaki, Japan

Nagano, Japan

Nagasaki, Japan

Niigata, Japan

Okayama, Japan

Okinawa, Japan

Osaka, Japan

Saga, Japan

Saitama, Japan

Shizuoka, Japan

Tokushima, Japan

Toyama, Japan

Yamagata, Japan