Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003907
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
1999-11-01
Brief Title:
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases A Phase II Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2023-06
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 Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor
PURPOSE Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed
PURPOSE Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed
Detailed Description:
OBJECTIVES
Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization
Evaluate tumor response achievable with chemoembolization in this patient population
Evaluate the toxicities of this treatment in these patients
Evaluate survival of these patients following this treatment
Evaluate extrahepatic patterns of failure following chemoembolization to determine whether intrahepatic progression may be forestalled and survival affected in these patients
Validate a consistent method of performing chemoembolization in a multicenter setting
OUTLINE Patients are stratified according to disease hepatocellular carcinoma vs neuroendocrine hepatic metastases
Patients undergo placement of a visceral arterial catheter Patients receive doxorubicin mitomycin and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only Immediately following delivery of the chemoemulsion particulate embolization is performed The opposite lobe if involved is treated within 3-5 weeks of treatment of the initial lobe
In the absence of unacceptable toxicity each involved lobe is treated separately a second time in the same sequence beginning 8 weeks after the last lobular chemoembolization After completion of all protocol therapy retreatment on study of either lobe is allowed for regrowth recurrence or new disease provided at least 3 months have elapsed since the initial treatment of that lobe
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 19-42 patients will be accrued for this study within 1 year
Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization
Evaluate tumor response achievable with chemoembolization in this patient population
Evaluate the toxicities of this treatment in these patients
Evaluate survival of these patients following this treatment
Evaluate extrahepatic patterns of failure following chemoembolization to determine whether intrahepatic progression may be forestalled and survival affected in these patients
Validate a consistent method of performing chemoembolization in a multicenter setting
OUTLINE Patients are stratified according to disease hepatocellular carcinoma vs neuroendocrine hepatic metastases
Patients undergo placement of a visceral arterial catheter Patients receive doxorubicin mitomycin and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only Immediately following delivery of the chemoemulsion particulate embolization is performed The opposite lobe if involved is treated within 3-5 weeks of treatment of the initial lobe
In the absence of unacceptable toxicity each involved lobe is treated separately a second time in the same sequence beginning 8 weeks after the last lobular chemoembolization After completion of all protocol therapy retreatment on study of either lobe is allowed for regrowth recurrence or new disease provided at least 3 months have elapsed since the initial treatment of that lobe
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 19-42 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E4298 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |