Real-world Data of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Advanced Gastric Cancer

Completed

• Conditions: Gastric Cancer Stage IV; Second-line Treatment; Ramucirumab Paclitaxel
• Interventions: Drug: Paclitaxel and ramucirumab

• Registration Number: NCT06666582
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2023-03-30
• Study Completion: 2024-01-15
• Study First Submitted: 2024-04-09
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
• Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
• Second-line treatment for advanced disease
• Treatment for at least two months of second-line treatment.

Exclusion Criteria

• Lack of informed consent in case the patient was alive

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who received other regimens as second-line treatment	Paclitaxel and ramucirumab	patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines, except from paclitaxel and ramucirumab. All other regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment.
Patients who received paclitaxel - ramucirumab as second-line treatment	Paclitaxel and ramucirumab	Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease with paclitaxel and ramucirumab, for at least two months.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years	The primary endpoint of interest was the assessment of progression-free survival (PFS1), defined as the time interval from the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years.	overall survival (OS), defined as the time interval from the date of disease progression to the date of death from any cause or last contact.

Trial Locations

Locations (1)

Hellenic Oncology Cooperative Group; 🇬🇷 Athens, Greece