drugset / Trial / NCT00956930

Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery

NCT00956930 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer. PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.

Timeline

Start
2009-08
Primary completion
2016-06-02
Completion
2016-07-15

Outcome

Met primary endpoint

registry Arm I (Radioembolization) vs Arm II (Transarterial Chemoembolization [TACE]); p = 0.007; Hazard Ratio (HR) 0.122 (95% CI 0.027 to 0.557); Log Rank NCT00956930 ↗

paper Patients in the Y90 radioembolization group had significant longer median TTP (>26 mo) than patients in the cTACE group (6.8 mo; P = .0012) PMID 27575820 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 75 mg Other

Indications