Spots Global Cancer Trial Database for Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
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Trial Identification
Brief Title: Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
Official Title: A Retrospective Study for Evaluation of Real-world Efficacy and Safety of Ramucirumab Plus Paclitaxel in Patients With Locally-advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study ID: NCT04192734
Interventions
Study Description
Brief Summary: This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review \& Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.
Detailed Description: Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Korea University Ansan Hospital, Ansan, , Korea, Republic of
Hallym University Sacred Heart Hospital, Anyang, , Korea, Republic of
Soonchunhyang University Bucheon Hospital, Bucheon, , Korea, Republic of
The Catholic University of Korea, Bucheon ST. Mary's Hospital, Bucheon, , Korea, Republic of
Dongnam Institute of Radiological&Medical Sciences, Busan, , Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Samsung Changwon medical center, Changwon, , Korea, Republic of
Gyeongsang National University Changwon Hospital, Changwon, , Korea, Republic of
Dankook University Hospital, Cheonan, , Korea, Republic of
Soonchunhyang University Cheonan Hospital, Cheonan, , Korea, Republic of
Chungbuk National University Hospital, Cheonju, , Korea, Republic of
Kangwon National University Hospital, Chuncheon, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
The Catholic University of Korea Daejeon ST. Mary's Hospital, Daejeon, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Gangneung Asan Hospital, Gangneung, , Korea, Republic of
National Cancer Center, Goyang, , Korea, Republic of
Chosun University Hospital, Gwangju, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Wonkwang University Hospital, Iksan, , Korea, Republic of
The Catholic University of Korea Incheon ST. Mary's Hospital, Incheon, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Gyeongsang National University Hospital, Jinju, , Korea, Republic of
Cha University Bundang Medical Center, Seongnam, , Korea, Republic of
Bundang Jesaeng Hospital, Seongnam, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Inje University Sanggye Paik Hospital, Seoul, , Korea, Republic of
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences, Seoul, , Korea, Republic of
KyungHee University Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Soonchunhyang University Seoul Hospital, Seoul, , Korea, Republic of
Konkuk University Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul ST. Mary's Hospital, Seoul, , Korea, Republic of
ChungAng University Hospital, Seoul, , Korea, Republic of
SMG-SNU Boramae Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Yeouido ST. Mary's Hospital, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea ST. Mary's Hospital, Suwon, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
The Catholic University of Korea Uijeongbu ST. Mary's Hospital, Uijeongbu, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Wonju Severance Christian Hospital, Wonju, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
Contact Details
Name: Dae Young Zang
Affiliation: Hallym University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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