Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
Real-world data, Gastric cancer, Gastroesophageal junction adenocarcinoma, Ramucirumab, Paclitaxel, Chemotherapy
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.
Interventions
DRUGRamucirumab and paclitaxel
Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started
DRUGTaxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy
Sponsors
Hallym University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Until September 30, 2023 | Time from the start of ramucirumab/paclitaxel to death from any cause |
| Progression-free survival | Until September 30, 2023 | Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of adverse events | Until September 30, 2023 | Number (percentage) of subjects reporting adverse events according to CTCAE v5.0 |
| 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 |
| Duration of response | Until September 30, 2023 | Time from documentation of tumor response to disease progression |
| Time to progression | Until September 30, 2023 | Time from the start of ramucirumab/paclitaxel to disease progression |
Countries
South Korea
Contacts
Primary ContactDae Young Zang
Backup ContactChi Hoon Maeng
Outcome results
None listed