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

March 22, 2021 updated by: Zang, Dae Young, Hallym University Medical Center

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1063

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of, 14584
        • SoonChunHyang University Bucheon Hospital
      • Bucheon, Korea, Republic of, 14647
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 46033
        • Dongnam Institute of Radiological&Medical Sciences
      • Changwon, Korea, Republic of, 51472
        • Gyeongsang National University Changwon Hospital
      • Changwon, Korea, Republic of, 51353
        • Samsung Changwon Medical Center
      • Cheonan, Korea, Republic of, 31116
        • Dankook University Hospital
      • Cheonan, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
      • Cheonju, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Chuncheon, Korea, Republic of, 24289
        • KangWon National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam national university hospital
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea Daejeon ST. Mary's hospital
      • Gangneung, Korea, Republic of, 25440
        • Gangneung Asan Hospital
      • Goyang, Korea, Republic of, 10408
        • National Cancer Center
      • Gwangju, Korea, Republic of, 61453
        • Chosun university hospital
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Iksan, Korea, Republic of, 54538
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea Incheon St. Mary's Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Jinju, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seongnam, Korea, Republic of, 13496
        • CHA University Bundang Medical Center
      • Seongnam, Korea, Republic of, 13590
        • Bundang Jesaeng Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 07345
        • The Catholic University of Korea Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 04401
        • SoonChunHyang University Seoul Hospital
      • Seoul, Korea, Republic of, 02447
        • KyungHee University Hospital
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic University of Korea St. Mary's Hospital
      • Uijeongbu, Korea, Republic of, 11765
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. Age ≥19 years at the time of study registration
  2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
  3. Locally advanced unresectable or metastatic disease
  4. Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma
  5. Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
Until September 30, 2019
Overall survival
Time Frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to death from any cause
Until September 30, 2019
Progression free survival
Time Frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause
Until September 30, 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: Until September 30, 2019
Time from documentation of tumor response to disease progression
Until September 30, 2019
Time to progression
Time Frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression
Until September 30, 2019
Objective response rate
Time Frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response
Until September 30, 2019
Disease control rate
Time Frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response or stable disease
Until September 30, 2019
Adverse events of special interest
Time Frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab plus paclitaxel
Until September 30, 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2019

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

October 30, 2020

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG ST19-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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