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RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. 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 and/or radiofrequency ablation in treating patients with liver cancer that cannot be removed by surgery.
- Compare and contrast radiofrequency ablation, chemoembolization, and radioembolization in order to determine either equivalence or superiority in patients with unresectable hepatocellular carcinoma.
- Compare the response rate at 6 months in patients with limited disease.
- Compare the time to progression in patients with more advanced disease.
- Characterize the safety and toxicity profile of these regimens.
- Determine the need for subsequent treatment in these patients.
- Determine tumor response in these patients
- Characterize change in quality of life and functional status in these patients.
- Determine time to progression in these patients.
OUTLINE: Patients are stratified according to tumor characteristics (ablatable vs non-ablatable disease).
- Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
- Arm II (radiofrequency ablation [RFA]): Patients undergo laparoscopic or percutaneous RFA for approximately 1-3 courses.
- Arm III (transarterial chemoembolization [TACE]): Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.
- Arm IV (TACE/RFA): Patients undergo TACE as in arm III followed by RFA as in arm II.
In all arms, treatment modifications may apply according to response.
After completion of study treatment, patients are followed every 3 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
cisplatin, doxorubicin hydrochloride, mitomycin C, radiofrequency ablation, yttrium Y 90 glass microspheres
Northwestern University, Northwestern Memorial Hospital
Published on BioPortfolio: 2014-08-27T03:20:08-0400
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