Real-world Data (RWD) of Ramucirumab Plus Paclitaxel

June 1, 2021 updated by: Zang, Dae Young, Hallym University Medical Center

A Prospective Study for Real-world Data (RWD) of Ramucirumab Plus Paclitaxel in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.

Researchers planned to prospectively collect RWD of ramucirumab/paclitaxel combination therapy as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Most drugs are introduced into the medical market based on efficacy derived from randomized controlled trials (RCTs) in a subset of patient groups in which the age, presence of comorbidities, and general conditions of the target patient are strictly controlled by the researcher.

Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.

Researchers have collected retrospective RWD from patients who used ramucirumab/paclitaxel in a previous study (KCSG ST19-16). Considering the limitations of RWD obtained through retrospective data collection, it is necessary to generate RWE through RWD, which prospectively collects various clinical data obtained in the process of using new anticancer drugs.

Study Type

Observational

Enrollment (Anticipated)

222

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang 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, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center

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 visiting university hospitals located in major cities in South Korea

Description

  1. Prospective population

    Inclusion Criteria:

    • Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
    • Patients with locally advanced or metastatic disease for which curative resection is not possible.
    • Patients who have failed fluoropyrimidine and platinum (cisplatin or oxaliplatin)-based chemotherapy as palliative first-line therapy
    • Patients who is starting ramucirumab/paclitaxel combination therapy after the study initiation date

    Exclusion Criteria:

    • Patients receiving ramucirumab monotherapy
    • Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
    • Patients unable to communicate or incapable of understanding documents for patient report outcomes
  2. Historical retrospective population

Inclusion Criteria:

  • Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
  • Patients with locally advanced or metastatic disease for which curative resection is not possible
  • Patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018

Exclusion Criteria:

  • Patients receiving ramucirumab monotherapy
  • Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective population
The target group for the purpose of prospectively collecting the clinical data (RWD) of patients using ramucirumab/paclitaxel as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Drug: Ramucirumab and paclitaxel
Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started
Other Names:
  • Prospective population
Historical retrospective population
The target group for the purpose of retrospectively collecting the clinical data (RWD) of patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018, when health insurance coverage for the ramucirumab/paclitaxel combination therapy started in South Korea.
Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy
Other Names:
  • Historical retrospective population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to death from any cause
Until September 30, 2023
Progression-free survival
Time Frame: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
Until September 30, 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Until September 30, 2023
Number (percentage) of subjects reporting adverse events according to CTCAE v5.0
Until September 30, 2023
Time to progression
Time Frame: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to disease progression
Until September 30, 2023
Objective response rate
Time Frame: Until September 30, 2023
The proportion of subjects confirmed complete or partial response according to RECIST v1.1
Until September 30, 2023
Disease control rate
Time Frame: Until September 30, 2023
The proportion of subjects confirmed complete response, partial response or stable disease according to RECIST v1.1
Until September 30, 2023
Duration of response
Time Frame: Until September 30, 2023
Time from documentation of tumor response to disease progression
Until September 30, 2023
Adverse events of special interest
Time Frame: Until September 30, 2023
Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab/paclitaxel: hypertension, proteinuria, gastrointestinal bleeding or perforation, delayed wound healing, deep vein thrombosis, arterial thrombosis, stroke according to on CTCAE v5.0
Until September 30, 2023

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG ST21-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Gastric Cancer

Clinical Trials on Ramucirumab and paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe