Real-world Data (RWD) of Ramucirumab Plus Paclitaxel

NCT04915807 | Unknown DMC

• 1 other identifier: KCSG ST21-06
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

Real-world data; Gastric cancer; Gastroesophageal junction adenocarcinoma; Ramucirumab; Paclitaxel; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Overall survival

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

  Until September 30, 2023

• Progression-free survival

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

  Until September 30, 2023

Secondary Outcomes (6)

• Incidence of adverse events

  Until September 30, 2023

• Time to progression

  Until September 30, 2023

• Objective response rate

  Until September 30, 2023

• Disease control rate

  Until September 30, 2023

• Duration of response

  Until September 30, 2023

Study Arms (2)

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

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

Interventions

Ramucirumab and paclitaxel DRUG

Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started

Also known as: Prospective population

Prospective population

Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy DRUG

Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy

Also known as: Historical retrospective population

Historical retrospective population

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting university hospitals located in major cities in South Korea

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (9)

Hallym University Sacred Heart Hospital

Anyang, 14068, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (13)

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• 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.

  PMID: 23942775 BACKGROUND

• 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.

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  PMID: 25240821 BACKGROUND

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  PMID: 20831302 BACKGROUND

Related Links

• Gastric Cancer: NCCN Guidelines Version 2.2021

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Ramucirumab; Paclitaxel; taxane; Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Dae Young Zang

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Young Zang

CONTACT

+82-31-380-4167; fhdzang@gmail.com

Chi Hoon Maeng

CONTACT

+82-2-958-2965; mchihoon@khu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

KR (9)