Conditions: Liver Cancer
Keywords: advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression.

Secondary

* 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 randomized to receive either TACE or Y90

* Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
* Arm II (transarterial chemoembolization \[TACE\]): Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.
* In both arms, treatment modifications may apply according to response.

After completion of study treatment, patients are followed every 3 months.

Arms:
arm 1: Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. arm 2: Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.

Interventions: intervention 1: yttrium Y 90 glass microspheres intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Patients undergo radioembolization. intervention 2: 75mg fixed dose

Protocol document: