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Gastric or Gastroesophageal Junction AdenocarcinomaNCT04192734

Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

An observational study of Gastric or Gastroesophageal Junction Adenocarcinoma, run by Hallym University Medical Center at 57 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
How many people
1,063 participants
Where
57 sitesSouth Korea
Study dates
18 Dec 2019to 30 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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

Who cannot join

  • Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System
  • Patients who have received ramucirumab monotherapy

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

South Korea57 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Hallym University Sacred Heart Hospital

    Anyang, 14068

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, 14584

  • The Catholic University of Korea, Bucheon ST. Mary's Hospital

    Bucheon-si, 14647

  • Dongnam Institute of Radiological&Medical Sciences

    Busan, 46033

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Kosin University Gospel Hospital

    Busan, 49267

  • Samsung Changwon medical center

    Changwon, 51353

  • Gyeongsang National University Changwon Hospital

    Changwon, 51472

  • Dankook University Hospital

    Cheonan, 31116

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151

  • Chungbuk National University Hospital

    Cheonju, 28644

  • Kangwon National University Hospital

    Chuncheon, 24289

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Yeungnam University Medical Center

    Daegu, 42415

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • The Catholic University of Korea Daejeon ST. Mary's Hospital

    Daejeon, 34943

  • Chungnam National University Hospital

    Daejeon, 35015

  • Gangneung Asan Hospital

    Gangneung, 25440

  • National Cancer Center

    Goyang, 10408

  • Chosun University Hospital

    Gwangju, 61453

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Wonkwang University Hospital

    Iksan, 54538

  • The Catholic University of Korea Incheon ST. Mary's Hospital

    Incheon, 21431

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Gyeongsang National University Hospital

    Jinju, 52727

  • Cha University Bundang Medical Center

    Seongnam, 13496

  • Bundang Jesaeng Hospital

    Seongnam, 13590

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Inje University Sanggye Paik Hospital

    Seoul, 01757

  • Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences

    Seoul, 01812

  • KyungHee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Soonchunhyang University Seoul Hospital

    Seoul, 04401

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul, 06591

  • ChungAng University Hospital

    Seoul, 06973

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • The Catholic University of Korea Yeouido ST. Mary's Hospital

    Seoul, 07345

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • Korea University Guro Hospital

    Seoul, 08308

  • The Catholic University of Korea ST. Mary's Hospital

    Suwon, 16247

  • Ajou University Hospital

    Suwon, 16499

  • The Catholic University of Korea Uijeongbu ST. Mary's Hospital

    Uijeongbu-si, 11765

  • Ulsan University Hosiptal

    Ulsan, 44033

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

About this study

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

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Time from the start of ramucirumab plus paclitaxel to death from any cause

    Measured: Until September 30, 2019

  2. Progression free survival

    Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause

    Measured: Until September 30, 2019

  3. Incidence of adverse events

    Number (percentage) of subjects reporting adverse events

    Measured: Until September 30, 2019

Secondary outcomes (5)

  1. Time to progression

    Time from the start of ramucirumab plus paclitaxel to disease progression

    Measured: Until September 30, 2019

  2. Objective response rate

    The proportion of subjects confirmed complete or partial response

    Measured: Until September 30, 2019

  3. Disease control rate

    The proportion of subjects confirmed complete or partial response or stable disease

    Measured: Until September 30, 2019

  4. Duration of response

    Time from documentation of tumor response to disease progression

    Measured: Until September 30, 2019

  5. Adverse events of special interest

    Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab plus paclitaxel

    Measured: Until September 30, 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start18 Dec 2019
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
1,063 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192734
Sponsor's protocol ID
KCSG ST19-16
Status last verified
Mar 2021
First submitted
5 Dec 2019
Last updated
24 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30913865

  • Bray 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.

    PubMed 30207593

  • Wagner 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.

    PubMed 16782930

  • Bang 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.

    PubMed 20728210

  • Kim 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.

    PubMed 23942775

  • Fuchs 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.

    PubMed 24094768

  • Wilke 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.

    PubMed 25240821

  • Smyth 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.

    PubMed 27664260

  • Muro 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.

    PubMed 30475956

  • Japanese 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.

    PubMed 27342689

  • Guideline 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.

    PubMed 30944757

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric or Gastroesophageal Junction Adenocarcinoma, run by Hallym University Medical Center at 57 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Until September 30, 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192734, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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