search
Back to results

Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cisplatin
brachytherapy
yttrium Y 90 glass microspheres
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically or cytologically confirmed hepatocellular carcinoma (HCC) Confined to the liver Vascular liver mass in the presence of cirrhosis Alpha-fetoprotein level > 500 ng/mL Measurable disease At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan Unresectable disease, due to tumor size or extent or presence of cirrhosis No metastatic disease, including brain metastases Locoregional lymph node metastases allowed No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments* No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 12 weeks Hematopoietic WBC > 2,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 60,000/mm^3 No bleeding diathesis not correctable by usual forms of therapy Hepatic See Disease Characteristics Bilirubin < 2.0 mg/dL AST and/or ALT ≤ 5 times upper limit of normal Hepatitis allowed No portal hypertension with hepatofugal flow Renal Creatinine < 2.5 mg/dL Cardiovascular No symptomatic congestive heart failure No severe peripheral vascular disease that would preclude catheterization Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment No ongoing or active infection No other uncontrolled illness No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 1 prior systemic chemotherapy for HCC More than 4 weeks since prior IV chemotherapy and recovered More than 1 year since prior hepatic arterial cisplatin More than 4 months since other prior hepatic arterial chemotherapy Endocrine therapy Not specified Radiotherapy No prior external hepatic radiotherapy for HCC Surgery Not specified Other No other concurrent therapy for HCC No other concurrent investigational agents

Sites / Locations

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Outcomes

Primary Outcome Measures

Progression-free survival as assessed by tumor progression in the treated lobe of the liver
Health-related quality of life at baseline and every 3 months
Toxicity as measured by NCI CTCAE version 3.0

Secondary Outcome Measures

Full Information

First Posted
May 3, 2005
Last Updated
January 15, 2016
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00109954
Brief Title
Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
Official Title
A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer. PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary Compare time to disease progression in patients with unresectable advanced hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®). Compare the health-related quality of life of patients treated with these regimens. Compare the safety of these regimens in these patients. Secondary Compare survival of patients treated with these regimens. Compare tumor response by CT scan in patients treated with these regimens. Compare treatment-related costs, in terms of cost of therapy and number of hospitalization days, in these patients. OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA) infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery (that brings blood to the tumor) on day 1. Treatment repeats every 8-10 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1. Beginning 60 days after the first TheraSphere® treatment, patients may receive additional treatment with TheraSphere® only if follow-up CT scans show progressive disease. Quality of life is assessed at baseline and then every 3 months thereafter. After the completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 glass microspheres
Primary Outcome Measure Information:
Title
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
Title
Health-related quality of life at baseline and every 3 months
Title
Toxicity as measured by NCI CTCAE version 3.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically or cytologically confirmed hepatocellular carcinoma (HCC) Confined to the liver Vascular liver mass in the presence of cirrhosis Alpha-fetoprotein level > 500 ng/mL Measurable disease At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan Unresectable disease, due to tumor size or extent or presence of cirrhosis No metastatic disease, including brain metastases Locoregional lymph node metastases allowed No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments* No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 12 weeks Hematopoietic WBC > 2,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 60,000/mm^3 No bleeding diathesis not correctable by usual forms of therapy Hepatic See Disease Characteristics Bilirubin < 2.0 mg/dL AST and/or ALT ≤ 5 times upper limit of normal Hepatitis allowed No portal hypertension with hepatofugal flow Renal Creatinine < 2.5 mg/dL Cardiovascular No symptomatic congestive heart failure No severe peripheral vascular disease that would preclude catheterization Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment No ongoing or active infection No other uncontrolled illness No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 1 prior systemic chemotherapy for HCC More than 4 weeks since prior IV chemotherapy and recovered More than 1 year since prior hepatic arterial cisplatin More than 4 months since other prior hepatic arterial chemotherapy Endocrine therapy Not specified Radiotherapy No prior external hepatic radiotherapy for HCC Surgery Not specified Other No other concurrent therapy for HCC No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian I. Carr, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery

We'll reach out to this number within 24 hrs