Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079027
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2004-03-08
Brief Title:
Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma Liver Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping the cells from dividing Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma liver cancer
PURPOSE This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery
PURPOSE This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization
Secondary
Compare the response rate in patients treated with these regimens
Compare time to progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the health economic implications of these regimens in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center stage of disease and alpha-fetoprotein levels 500 ngmL vs 500 ngmL Patients are randomized to 1 of 2 treatment arms
Arm I control arm Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II chemoembolization arm Patients undergo transarterial chemoembolization using DC Bead and doxorubicin hydrochloride Chemoembolization repeats every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 10 and 24
Patients are followed at 4 weeks and then every 12 weeks thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study
Primary
Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization
Secondary
Compare the response rate in patients treated with these regimens
Compare time to progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the health economic implications of these regimens in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center stage of disease and alpha-fetoprotein levels 500 ngmL vs 500 ngmL Patients are randomized to 1 of 2 treatment arms
Arm I control arm Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II chemoembolization arm Patients undergo transarterial chemoembolization using DC Bead and doxorubicin hydrochloride Chemoembolization repeats every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 10 and 24
Patients are followed at 4 weeks and then every 12 weeks thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN78345798 | None | None | None |
| CRUK-HEP-1 | None | None | None |
| EU-20340 | None | None | None |