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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Stage IV Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Ramucirumab Paclitaxel Second-line Treatment Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hellenic Oncology Cooperative Group

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel and ramucirumab

Drug

Second-line treatment with paclitaxel/ramucirumab vs other regimens

Primary outcomes

Progression-free survival

Time frame: 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 outcomes

Overall survival

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

Real-world Efficacy and Toxicity Data of the Combination of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Patients With Advanced Gastric Cancer

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2024
First posted: Oct 30, 2024
Registry last updated: Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed