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

Sponsor
Hallym University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04192734
Collaborator
(none)
1,063
Enrollment
57
Locations
10.4
Actual Duration (Months)
18.6
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1063 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Dec 18, 2019
    Actual Primary Completion Date :
    Oct 30, 2020
    Actual Study Completion Date :
    Oct 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [Until September 30, 2019]

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

    2. Progression free survival [Until September 30, 2019]

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

    3. Incidence of adverse events [Until September 30, 2019]

      Number (percentage) of subjects reporting adverse events

    Secondary Outcome Measures

    1. Time to progression [Until September 30, 2019]

      Time from the start of ramucirumab plus paclitaxel to disease progression

    2. Objective response rate [Until September 30, 2019]

      The proportion of subjects confirmed complete or partial response

    3. Disease control rate [Until September 30, 2019]

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

    4. Duration of response [Until September 30, 2019]

      Time from documentation of tumor response to disease progression

    5. Adverse events of special interest [Until September 30, 2019]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Ansan Hospital Ansan Korea, Republic of 15355
    2 Hallym University Sacred Heart Hospital Anyang Korea, Republic of 14068
    3 Soonchunhyang University Bucheon Hospital Bucheon Korea, Republic of 14584
    4 The Catholic University of Korea, Bucheon ST. Mary's Hospital Bucheon Korea, Republic of 14647
    5 Dongnam Institute of Radiological&Medical Sciences Busan Korea, Republic of 46033
    6 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    7 Dong-A University Hospital Busan Korea, Republic of 49201
    8 Pusan National University Hospital Busan Korea, Republic of 49241
    9 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    10 Samsung Changwon medical center Changwon Korea, Republic of 51353
    11 Gyeongsang National University Changwon Hospital Changwon Korea, Republic of 51472
    12 Dankook University Hospital Cheonan Korea, Republic of 31116
    13 Soonchunhyang University Cheonan Hospital Cheonan Korea, Republic of 31151
    14 Chungbuk National University Hospital Cheonju Korea, Republic of 28644
    15 Kangwon National University Hospital Chuncheon Korea, Republic of 24289
    16 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    17 Yeungnam University Medical Center Daegu Korea, Republic of 42415
    18 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 42601
    19 The Catholic University of Korea Daejeon ST. Mary's Hospital Daejeon Korea, Republic of 34943
    20 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    21 Gangneung Asan Hospital Gangneung Korea, Republic of 25440
    22 National Cancer Center Goyang Korea, Republic of 10408
    23 Chosun University Hospital Gwangju Korea, Republic of 61453
    24 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 58128
    25 Wonkwang University Hospital Iksan Korea, Republic of 54538
    26 The Catholic University of Korea Incheon ST. Mary's Hospital Incheon Korea, Republic of 21431
    27 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    28 Inha University Hospital Incheon Korea, Republic of 22332
    29 Chonbuk National University Hospital Jeonju Korea, Republic of 54907
    30 Gyeongsang National University Hospital Jinju Korea, Republic of 52727
    31 Cha University Bundang Medical Center Seongnam Korea, Republic of 13496
    32 Bundang Jesaeng Hospital Seongnam Korea, Republic of 13590
    33 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620
    34 Inje University Sanggye Paik Hospital Seoul Korea, Republic of 01757
    35 Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences Seoul Korea, Republic of 01812
    36 KyungHee University Hospital Seoul Korea, Republic of 02447
    37 Korea University Anam Hospital Seoul Korea, Republic of 02841
    38 Seoul National University Hospital Seoul Korea, Republic of 03080
    39 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    40 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    41 Soonchunhyang University Seoul Hospital Seoul Korea, Republic of 04401
    42 Konkuk University Medical Center Seoul Korea, Republic of 05030
    43 Asan Medical Center Seoul Korea, Republic of 05505
    44 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    45 Samsung Medical Center Seoul Korea, Republic of 06351
    46 The Catholic University of Korea Seoul ST. Mary's Hospital Seoul Korea, Republic of 06591
    47 ChungAng University Hospital Seoul Korea, Republic of 06973
    48 SMG-SNU Boramae Medical Center Seoul Korea, Republic of 07061
    49 The Catholic University of Korea Yeouido ST. Mary's Hospital Seoul Korea, Republic of 07345
    50 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 07985
    51 Korea University Guro Hospital Seoul Korea, Republic of 08308
    52 The Catholic University of Korea ST. Mary's Hospital Suwon Korea, Republic of 16247
    53 Ajou University Hospital Suwon Korea, Republic of 16499
    54 The Catholic University of Korea Uijeongbu ST. Mary's Hospital Uijeongbu Korea, Republic of 11765
    55 Ulsan University Hosiptal Ulsan Korea, Republic of 44033
    56 Wonju Severance Christian Hospital Wonju Korea, Republic of 26426
    57 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 50612

    Sponsors and Collaborators

    • Hallym University Medical Center

    Investigators

    • Principal Investigator: Dae Young Zang, Hallym University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Zang, Dae Young, Dae Young Zang MD, PhD, Hallym University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04192734
    Other Study ID Numbers:
    • KCSG ST19-16
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Mar 24, 2021