drugset / Trial / NCT07411144

Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma

NCT07411144 ↗

Phase 2 Completed 64 enrolled National Cancer Institute, Egypt
RandomizedParallel-groupOpen-labelTreatment

Summary

What is this study about? This study looks at whether continuing chemotherapy with a drug called gemcitabine after initial treatment can help patients with diffuse pleural mesothelioma keep their cancer under control for a longer time. Diffuse pleural mesothelioma is a rare and aggressive cancer that affects the lining of the lungs. Even after standard chemotherapy, the disease often comes back quickly. Doctors are therefore looking for maintenance treatments that may delay cancer progression. What does this mean for patients and families? Gemcitabine maintenance treatment may help delay cancer progression It does not clearly extend overall life expectancy Side effects are common and should be carefully discussed with the treating oncologist Treatment decisions should consider: Patient performance status Symptoms Personal preferences and quality of life What does this mean for health care providers? Gemcitabine maintenance may be an option for: Fit patients Those who responded to first-line chemotherapy Careful patient selection is essential Monitoring for hematologic toxicity is required Further larger studies are needed to confirm survival benefit

Timeline

Start
2020-03-15
Primary completion
2023-03-15
Completion
2023-03-15

Outcome

Met primary endpoint

paper Gemcitabine maintenance therapy significantly improved PFS (median: 6.2 months vs. 2.8 months; HR: 4.33, 95% CI: 2.48–7.56, p < 0.001). PMID 41888696 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous