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

NCT06666582 | Completed

• 1 other identifier: RE721
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  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

Secondary Outcomes (1)

• 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.

Study Arms (2)

Patients who received paclitaxel - ramucirumab as second-line treatment

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.

Drug: Paclitaxel and ramucirumab

Patients who received other regimens as second-line treatment

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.

Drug: Paclitaxel and ramucirumab

Interventions

Paclitaxel and ramucirumab DRUG

Second-line treatment with paclitaxel/ramucirumab vs other regimens

Patients who received other regimens as second-line treatment; Patients who received paclitaxel - ramucirumab as second-line treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included 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. All 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. Patient clinicopathological characteristics and outcome data were retrospectively recorded from patient medical records. Toxicity data were retrospectively recorded from the clinicians' documentations of patient-reported symptoms and laboratory results during scheduled clinical visits or patient hospitalizations.

You may qualify if:

• 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.

You may not qualify if:

• Lack of informed consent in case the patient was alive

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Oncology Cooperative Group

Athens, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: October 30, 2024
• Study Start: March 1, 2015
• Primary Completion: March 30, 2023
• Study Completion: January 15, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

GR (1)