Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109954
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2005-05-03
Brief Title:
Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCI-IRB-0501021 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000425333 | REGISTRY | None | None |