Spots Global Cancer Trial Database for Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
Official Title: A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
Study ID: NCT01813253
Study Description
Brief Summary: This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
Detailed Description: This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
, Aichi, , Japan
, Akita, , Japan
, Aomori, , Japan
, Chiba, , Japan
, Ehime, , Japan
, Fukuoka, , Japan
, Hiroshima, , Japan
, Hokkaido, , Japan
, Hyogo, , Japan
, Ishikawa, , Japan
, Kanagawa, , Japan
, Kumamoto, , Japan
, Kyoto, , Japan
, Nagano, , Japan
, Niigata, , Japan
, Osaka, , Japan
, Saitama, , Japan
, Shizuoka, , Japan
, Shizuoka, , Japan
, Tochigi, , Japan
, Tokyo, , Japan
, Toyama, , Japan
, Busan, , Korea, Republic of
, Daegu, , Korea, Republic of
Hwansun Junnam hospital, Gwangju, , Korea, Republic of
, Gyeonggi-do, , Korea, Republic of
, Incheon, , Korea, Republic of
, Jeonju, , Korea, Republic of
, Seongnam, , Korea, Republic of
, Seoul, , Korea, Republic of
, Yangsan, , Korea, Republic of
, Changhua, , Taiwan
, Tainan, , Taiwan
, Taipei, , Taiwan
, Taoyuan, , Taiwan
, Thaichung, , Taiwan
Contact Details
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