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NCT Number: NCT04192734

Retrospective Study of Ramucirumab and Paclitaxel in 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: Until September 30, 2019

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

  2. 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

  3. Incidence of adverse events

    Time frame: Until September 30, 2019

    Number (percentage) of subjects reporting adverse events

Secondary outcomes

  1. Time to progression

    Time frame: Until September 30, 2019

    Time from the start of ramucirumab plus paclitaxel to disease progression

  2. Objective response rate

    Time frame: Until September 30, 2019

    The proportion of subjects confirmed complete or partial response

  3. Disease control rate

    Time frame: Until September 30, 2019

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

  4. Duration of response

    Time frame: Until September 30, 2019

    Time from documentation of tumor response to disease progression

  5. 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

Sponsors and collaborators

Lead sponsor

Hallym University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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