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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06666582
Enrollment
185
Registered
2024-10-30
Start date
2015-03-01
Completion date
2024-01-15
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer Stage IV, Ramucirumab Paclitaxel, Second-line Treatment

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).

Interventions

DRUGPaclitaxel and ramucirumab

Second-line treatment with paclitaxel/ramucirumab vs other regimens

Sponsors

Hellenic Cooperative Oncology Group
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survivalFrom 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 yearsThe 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

MeasureTime frameDescription
Overall survivalFrom 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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026