Sorafenib Alone or in Combination With Everolimus in Patients With Unresectable Hepatocellular Carcinoma. A Randomized Multicenter Phase II Trial.
OBJECTIVES:
- To determine if sorafenib tosylate with versus without everolimus can stop tumor
progression in patients with localized, unresectable, or metastatic hepatocellular
carcinoma.
- To evaluate changes in symptom-related and global quality of life (QL) and QL benefit
over the course of trial treatment in these patients.
- To compare the primary endpoint (i.e., progression-free survival at week 12) to the QL
benefit within 12 weeks from baseline.
- To evaluate how symptom-related and global QL indicators map on the single summary
index derived from a standardized measure of health status for utility cost analysis.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance
status (0 vs 1), disease spread (extrahepatic spread vs non-extrahepatic spread), and
center. Patients are randomized to 1 of 2 treatment arms.
- Arm A (standard treatment): Patients receive oral sorafenib tosylate twice daily for 4
weeks. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
- Arm B (investigational treatment): Patients receive oral sorafenib tosylate twice daily
and oral everolimus once daily for 4 weeks. Courses repeat every 4 weeks in the absence
of disease progression or unacceptable toxicity.
Some patients may undergo CT scan or MRI at baseline and at 6 and 12 weeks during study to
assess tumor response, tumor size, and tumor density.
Patients complete quality of life questionnaires at baseline and every 2 weeks for 12 weeks
during study treatment.
After completion of study treatment, patients are followed every 2 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
at 12 weeks
No
Dieter Koeberle, MD
Study Chair
Kantonsspital St. Gallen
Switzerland: Swissmedic
SAKK 77/08 and SASL 29
NCT01005199
November 2009
June 2017
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