Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
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
1 other identifier
observational
1,063
1 country
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Shorter than P25 for all trials
57 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
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedMarch 24, 2021
March 1, 2021
11 months
December 5, 2019
March 22, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Overall survival
Time from the start of ramucirumab plus paclitaxel to death from any cause
Until September 30, 2019
Progression free survival
Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause
Until September 30, 2019
Incidence of adverse events
Number (percentage) of subjects reporting adverse events
Until September 30, 2019
Secondary Outcomes (5)
Time to progression
Until September 30, 2019
Objective response rate
Until September 30, 2019
Disease control rate
Until September 30, 2019
Duration of response
Until September 30, 2019
Adverse events of special interest
Until September 30, 2019
Eligibility Criteria
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 under the Korea National Health Insurance System
You may qualify if:
- Age ≥19 years at the time of study registration
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Locally advanced unresectable or metastatic disease
- Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma
- Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System
You may not qualify if:
- Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System
- Patients who have received ramucirumab monotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Korea University Ansan Hospital
Ansan, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, 14647, South Korea
Dongnam Institute of Radiological&Medical Sciences
Busan, 46033, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Samsung Changwon medical center
Changwon, 51353, South Korea
Gyeongsang National University Changwon Hospital
Changwon, 51472, South Korea
Dankook University Hospital
Cheonan, 31116, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, 31151, South Korea
Chungbuk National University Hospital
Cheonju, 28644, South Korea
Kangwon National University Hospital
Chuncheon, 24289, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Keimyung University Dongsan Medical Center
Daegu, 42601, South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, 34943, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Gangneung Asan Hospital
Gangneung, 25440, South Korea
National Cancer Center
Goyang, 10408, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Wonkwang University Hospital
Iksan, 54538, South Korea
The Catholic University of Korea Incheon ST. Mary's Hospital
Incheon, 21431, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chonbuk National University Hospital
Jeonju, 54907, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Cha University Bundang Medical Center
Seongnam, 13496, South Korea
Bundang Jesaeng Hospital
Seongnam, 13590, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Inje University Sanggye Paik Hospital
Seoul, 01757, South Korea
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812, South Korea
KyungHee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Soonchunhyang University Seoul Hospital
Seoul, 04401, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, 06591, South Korea
ChungAng University Hospital
Seoul, 06973, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
The Catholic University of Korea Yeouido ST. Mary's Hospital
Seoul, 07345, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University of Korea ST. Mary's Hospital
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
The Catholic University of Korea Uijeongbu ST. Mary's Hospital
Uijeongbu-si, 11765, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Related Publications (11)
Jung KW, Won YJ, Kong HJ, Lee ES. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016. Cancer Res Treat. 2019 Apr;51(2):417-430. doi: 10.4143/crt.2019.138. Epub 2019 Mar 18.
PMID: 30913865RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PMID: 30207593RESULTWagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.
PMID: 16782930RESULTBang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PMID: 20728210RESULTKim HS, Kim HJ, Kim SY, Kim TY, Lee KW, Baek SK, Kim TY, Ryu MH, Nam BH, Zang DY. Second-line chemotherapy versus supportive cancer treatment in advanced gastric cancer: a meta-analysis. Ann Oncol. 2013 Nov;24(11):2850-4. doi: 10.1093/annonc/mdt351. Epub 2013 Aug 13.
PMID: 23942775RESULTFuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
PMID: 24094768RESULTWilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
PMID: 25240821RESULTSmyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
PMID: 27664260RESULTMuro K, Van Cutsem E, Narita Y, Pentheroudakis G, Baba E, Li J, Ryu MH, Zamaniah WIW, Yong WP, Yeh KH, Kato K, Lu Z, Cho BC, Nor IM, Ng M, Chen LT, Nakajima TE, Shitara K, Kawakami H, Tsushima T, Yoshino T, Lordick F, Martinelli E, Smyth EC, Arnold D, Minami H, Tabernero J, Douillard JY. Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic gastric cancer: a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS. Ann Oncol. 2019 Jan 1;30(1):19-33. doi: 10.1093/annonc/mdy502.
PMID: 30475956RESULTJapanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
PMID: 27342689RESULTGuideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. No abstract available.
PMID: 30944757RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Dae Young Zang
Hallym University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dae Young Zang MD, PhD
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 10, 2019
Study Start
December 18, 2019
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
March 24, 2021
Record last verified: 2021-03