Real-world Data (RWD) of Ramucirumab Plus Paclitaxel
- Conditions
- Gastric CancerGastroesophageal Junction Adenocarcinoma
- Interventions
- Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
- Registration Number
- NCT04915807
- Lead Sponsor
- Hallym University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 222
- 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
- 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective population Ramucirumab and paclitaxel 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 Historical retrospective population Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy 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.
- Primary Outcome Measures
Name Time Method Progression-free survival Until September 30, 2023 Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
Overall survival Until September 30, 2023 Time from the start of ramucirumab/paclitaxel to death from any cause
- Secondary Outcome Measures
Name Time Method Adverse events of special interest 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
Time to progression Until September 30, 2023 Time from the start of ramucirumab/paclitaxel to disease progression
Duration of response Until September 30, 2023 Time from documentation of tumor response to disease progression
Incidence of adverse events Until September 30, 2023 Number (percentage) of subjects reporting adverse events according to CTCAE v5.0
Objective response rate Until September 30, 2023 The proportion of subjects confirmed complete or partial response according to RECIST v1.1
Disease control rate Until September 30, 2023 The proportion of subjects confirmed complete response, partial response or stable disease according to RECIST v1.1
Trial Locations
- Locations (9)
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of