Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121914
Status:
UNKNOWN
Last Update Posted:
2005-10-18
First Post:
2005-07-15
Brief Title:
Treatment of Hepatocellular Carcinoma Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation PEI Versus Long-Acting Somatostatin Alone
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Treatment of Hepatocellular Carcinoma A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation PEI Versus Long-Acting Somatostatin Alone
Status:
UNKNOWN
Status Verified Date:
2005-07
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:
Hepatocellular carcinoma HCC is a consequence of liver cirrhosis In early tumour stages tumour resection or liver transplantation are therapeutic options later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation PEI transarterial chemoembolization TACE or radio-frequency thermoablation This randomized study investigates the effect of PEI on survival of patients with HCC All patients will receive hormonal treatment long-acting somatostatin intramuscularly im and will be randomized for treatment with PEI or no additional treatment
Detailed Description:
This is a randomized two-arm parallel group study
Study group PEI long-acting somatostatin
Control group long-acting somatostatin alone
Aims of the study
Does treatment with PEI long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone
Can time to tumour progression be extended in patients treated with PEI long-acting somatostatin as compared to treatment with long-acting somatostatin alone
Study group PEI long-acting somatostatin
Control group long-acting somatostatin alone
Aims of the study
Does treatment with PEI long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone
Can time to tumour progression be extended in patients treated with PEI long-acting somatostatin as compared to treatment with long-acting somatostatin alone
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