Clinical trial NCT04915807: Real-world Data (RWD) of Ramucirumab Plus Paclitaxel
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Keywords: Real-world data
Gastric cancer
Gastroesophageal junction adenocarcinoma
Ramucirumab
Paclitaxel
Chemotherapy
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 222
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting university hospitals located in major cities in South Korea

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Until September 30, 2023
measure: Progression-free survival
timeFrame: Until September 30, 2023
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Until September 30, 2023
measure: Time to progression
timeFrame: Until September 30, 2023
measure: Objective response rate
timeFrame: Until September 30, 2023
measure: Disease control rate
timeFrame: Until September 30, 2023
measure: Duration of response
timeFrame: Until September 30, 2023
measure: Adverse events of special interest
timeFrame: Until September 30, 2023
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Hallym University Medical Center
name: Dae Young Zang
role: PRINCIPAL_INVESTIGATOR
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