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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I (radioembolization)	yttrium Y 90 glass microspheres	Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
Arm II (transarterial chemoembolization [TACE])	Doxorubicin	Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP) in Patients Treated With TACE and Y90	Up to 6 yrs	Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. Patients have repeat imaging done (MRI or CT) at 1-month post procedure and then every 3 months after that. TTP and overall survival (OS) analyses were calculated from day of randomization by Kaplan-Meier analysis on intention-to-treat (ITT) basis. Progression (which is detected on follow-up imaging scans) was defined as: 1. Progression by World Health Organization (WHO) response criteria 25% increase in bidimensional cross product. 2. Progression by European Assosciation for the Study of the Liver (EASL): 25% increase in arterial enhancement 3. Malignant portal vein tumor thrombus development 4. Index lesion: lesions requiring re-treatment because of worsening circumferential enhancement 5. Development of new lesions or extra-hepatic metastases.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment	up to 6 years	Repeat imaging (CT/MRI) and lab work including tumor markers will be assessed 1 month post-treatment then every 3 months after that. Both EASL \& WHO criteria are used. By EASL criteria Complete response is 100% Decrease in amount of enhancing tissue in index lesion, Partial response is ≥50% deecrease in amount of enhancing tissue in index lesion, Stable disease is \<50% Decrease in to ≤ 25% increase in amount of enhancing tissue in index lesion, Progressive disease \<25% Increase in amount of enhancing tissue in index lesion and/or new enhancement in previously treated index lesion.
Overall Survival	From day of randomization until date of death, or liver transplant or 7/15/2016, whichever came first, assessed up to 6 years	Comparing overall survival of both treatment arms.

Locations (1): Northwestern University, Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States