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
4 other identifiers
observational
757
1 country
151
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 13, 2026
April 1, 2026
12.3 years
March 16, 2015
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes.
Up to approximately 63 months
Secondary Outcomes (10)
Progression-Free Survival (PFS)
Up to approximately 63 months
Response Rate (RR)
Approximately 12 months
Duration of Response (DOR)
Up to approximately 63 months
Percentage of Participants who Proceeded to Surgical Resection
Up to approximately 63 month
Percentage of Participants with Early Tumor Shrinkage
Up to approximately 63 months
- +5 more secondary outcomes
Study Arms (2)
Group P; mFOLFOX6 + panitumumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks
Group B; mFOLFOX6 + bevacizumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks
Interventions
oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
Eligibility Criteria
Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study.
You may qualify if:
- (1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
You may not qualify if:
- (1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (151)
Unknown Facility
Ichinomiya, Aichi-ken, Japan
Unknown Facility
Komaki, Aichi-ken, Japan
Unknown Facility
Kounan, Aichi-ken, Japan
Unknown Facility
Nagakute, Aichi-ken, Japan
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Okazaki, Aichi-ken, Japan
Unknown Facility
Toyohashi, Aichi-ken, Japan
Unknown Facility
Toyokawa, Aichi-ken, Japan
Unknown Facility
Toyota, Aichi-ken, Japan
Unknown Facility
Yatomi, Aichi-ken, Japan
Unknown Facility
Daisen, Akita, Japan
Unknown Facility
Hirosaki, Aomori, Japan
Unknown Facility
Misawa, Aomori, Japan
Unknown Facility
Kashiwa, Chiba, Japan
Unknown Facility
Yachiyo, Chiba, Japan
Unknown Facility
Matsuyama, Ehime, Japan
Unknown Facility
Tōon, Ehime, Japan
Unknown Facility
Tsuruga, Fukui, Japan
Unknown Facility
Yoshida, Fukui, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Koga, Fukuoka, Japan
Unknown Facility
Koga, Fukuoka, Japan
Unknown Facility
Kurume, Fukuoka, Japan
Unknown Facility
Omuta, Fukuoka, Japan
Unknown Facility
Aizu-Wakamatsu, Fukushima, Japan
Unknown Facility
Iwaki, Fukushima, Japan
Unknown Facility
Kōriyama, Fukushima, Japan
Unknown Facility
Shirakawa, Fukushima, Japan
Unknown Facility
Hashima, Gifu, Japan
Unknown Facility
Kakamigahara, Gifu, Japan
Unknown Facility
Minokamo, Gifu, Japan
Unknown Facility
Okazai, Gifu, Japan
Unknown Facility
Ōgaki, Gifu, Japan
Unknown Facility
Maebashi, Gunma, Japan
Unknown Facility
Ōta, Gunma, Japan
Unknown Facility
Fukuyama, Hiroshima, Japan
Unknown Facility
Hakodate, Hokkaido, Japan
Unknown Facility
Kitami, Hokkaido, Japan
Unknown Facility
Kushiro, Hokkaido, Japan
Unknown Facility
Obihiro, Hokkaido, Japan
Unknown Facility
Otaru, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Akashi, Hyōgo, Japan
Unknown Facility
Amagasaki, Hyōgo, Japan
Unknown Facility
Himeji, Hyōgo, Japan
Unknown Facility
Kobe, Hyōgo, Japan
Unknown Facility
Nishinomiya, Hyōgo, Japan
Unknown Facility
Hitachi, Ibaraki, Japan
Unknown Facility
Kasama, Ibaraki, Japan
Unknown Facility
Ryūgasaki, Ibaraki, Japan
Unknown Facility
Tsuchiura, Ibaraki, Japan
Unknown Facility
Tsukuba, Ibaraki, Japan
Unknown Facility
Hakusan, Ishikawa-ken, Japan
Unknown Facility
Kaga, Ishikawa-ken, Japan
Unknown Facility
Kahoku, Ishikawa-ken, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, Japan
Unknown Facility
Nanao, Ishikawa-ken, Japan
Unknown Facility
Morioka, Iwate, Japan
Unknown Facility
Kida, Kagawa-ken, Japan
Unknown Facility
Marugame, Kagawa-ken, Japan
Unknown Facility
Takamatsu, Kagawa-ken, Japan
Unknown Facility
Fujisawa, Kanagawa, Japan
Unknown Facility
Hiratsuka, Kanagawa, Japan
Unknown Facility
Isehara, Kanagawa, Japan
Unknown Facility
Kamakura, Kanagawa, Japan
Unknown Facility
Kanazawachō, Kanagawa, Japan
Unknown Facility
Sagamihara, Kanagawa, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Yokosuka, Kanagawa, Japan
Unknown Facility
Nankoku, Kochi, Japan
Unknown Facility
Matsuzaka, Mie-ken, Japan
Unknown Facility
Tsu, Mie-ken, Japan
Unknown Facility
Yokkaichi, Mie-ken, Japan
Unknown Facility
Ishinomaki, Miyagi, Japan
Unknown Facility
Murata, Miyagi, Japan
Unknown Facility
Natori-shi, Miyagi, Japan
Unknown Facility
Ōsaki, Miyagi, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Matsumoto, Nagano, Japan
Unknown Facility
Saku, Nagano, Japan
Unknown Facility
Ōmura, Nagasaki, Japan
Unknown Facility
Sasebo, Nagasaki, Japan
Unknown Facility
Ikoma, Nara, Japan
Unknown Facility
Tenri, Nara, Japan
Unknown Facility
Yamatotakada, Nara, Japan
Unknown Facility
Yufu, Oita Prefecture, Japan
Unknown Facility
Kurashiki, Okayama-ken, Japan
Unknown Facility
Naha, Okinawa, Japan
Unknown Facility
Tomigusuku, Okinawa, Japan
Unknown Facility
Urasoe, Okinawa, Japan
Unknown Facility
Hirakata, Osaka, Japan
Unknown Facility
Kawachi-Nagano, Osaka, Japan
Unknown Facility
Moriguchi, Osaka, Japan
Unknown Facility
Neyagawa, Osaka, Japan
Unknown Facility
Sayama, Osaka, Japan
Unknown Facility
Suita, Osaka, Japan
Unknown Facility
Takatsuki, Osaka, Japan
Unknown Facility
Kawagoe, Saitama, Japan
Unknown Facility
Kitaadachi, Saitama, Japan
Unknown Facility
Koshigaya, Saitama, Japan
Unknown Facility
Moriyama, Shiga, Japan
Unknown Facility
Ōtsu, Shiga, Japan
Unknown Facility
Izumi, Shimane, Japan
Unknown Facility
Izumo, Shimane, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Unknown Facility
Izunokuni, Shizuoka, Japan
Unknown Facility
Sunto, Shizuoka, Japan
Unknown Facility
Shimotsuga, Tochigi, Japan
Unknown Facility
Shimotsuke, Tochigi, Japan
Unknown Facility
Utsunomiya, Tochigi, Japan
Unknown Facility
Komatsushimachō, Tokushima, Japan
Unknown Facility
Bunkyo-ku, Tokyo, Japan
Unknown Facility
Chiyoda-ku, Tokyo, Japan
Unknown Facility
Chuo-ku, Tokyo, Japan
Unknown Facility
Itabashi-ku, Tokyo, Japan
Unknown Facility
Koto-ku, Tokyo, Japan
Unknown Facility
Machida, Tokyo, Japan
Unknown Facility
Minato-ku, Tokyo, Japan
Unknown Facility
Musashino, Tokyo, Japan
Unknown Facility
Shinagawa-ku, Tokyo, Japan
Unknown Facility
Shinjyuku-ku, Tokyo, Japan
Unknown Facility
Yonago, Tottori, Japan
Unknown Facility
Kurobe-shi, Toyama, Japan
Unknown Facility
Takaoka, Toyama, Japan
Unknown Facility
Sakata, Yamagata, Japan
Unknown Facility
Tsuruoka, Yamagata, Japan
Unknown Facility
Iwakuni, Yamaguchi, Japan
Unknown Facility
Kofu, Yamanashi, Japan
Unknown Facility
Akita, Japan
Unknown Facility
Aomori, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Fukui, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Gifu, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Kochi, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Miyazaki, Japan
Unknown Facility
Nagano, Japan
Unknown Facility
Nagasaki, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Okinawa, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Saga, Japan
Unknown Facility
Saitama, Japan
Unknown Facility
Shizuoka, Japan
Unknown Facility
Tokushima, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Yamagata, Japan
Related Publications (2)
Shitara K, Muro K, Watanabe J, Yamazaki K, Ohori H, Shiozawa M, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Mori I, Yamanaka K, Hihara M, Soeda J, Misumi T, Yamamoto K, Yamashita R, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer. Nat Med. 2024 Mar;30(3):730-739. doi: 10.1038/s41591-023-02791-w. Epub 2024 Feb 12.
PMID: 38347302DERIVEDYoshino T, Uetake H, Tsuchihara K, Shitara K, Yamazaki K, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Yamanaka K, Iwasaki K, Soeda J, Hihara M, Yamanaka T, Ochiai A, Muro K. Rationale for and Design of the PARADIGM Study: Randomized Phase III Study of mFOLFOX6 Plus Bevacizumab or Panitumumab in Chemotherapy-naive Patients With RAS (KRAS/NRAS) Wild-type, Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2017 Jun;16(2):158-163. doi: 10.1016/j.clcc.2017.01.001. Epub 2017 Jan 24.
PMID: 28237539DERIVED
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 20, 2015
Study Start
May 29, 2015
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.