Real-world Data (RWD) of Ramucirumab Plus Paclitaxel

Hallym University

Status: Unknown

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy; Drug: Ramucirumab and paclitaxel

Study type: Observational

Funder types: Other

Identifiers

NCT04915807

KCSG ST21-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

222 participants in 2 patient groups

Prospective population

Description:

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

Treatment:

Drug: Ramucirumab and paclitaxel

Historical retrospective population

Description:

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.

Treatment:

Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy