Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356161
Status:
UNKNOWN
Last Update Posted:
2006-07-25
First Post:
2006-07-24
Brief Title:
HAI Via Interventionally Implanted Port Catheter Systems
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Open One-Arm Therapy Optimizing Trial on Regional Chemotherapy of the Liver Through an Interventionally Implanted AHepatica Port System in Patients With Liver Metastases or Primary Liver Neoplasms
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
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:
Procedures to provide interventional implantation of a port catheter system into the hepatic artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open single-arm trial in patients with metastases and cancers confined to the liver The primary objective is the improvement of indication implantation procedure and regional chemotherapy Secondary objectives are port patency comparison of complications with a historical collective of patients provided with a surgical hepatic arterial port device colorectal cancer patients only progression free and overall survival efficacy of maintaining regional chemotherapy with 5-FU in combination with systemic treatment in patients with extrahepatic progression quality of life
Detailed Description:
Inclusion criteria
histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation
non-resectable disease or hepatic resection or ablation in between the past 8 weeks
measurable disease at least before hepatic resection
Karnofsky performance status 70 or ECOG status 0-2
18 years of age
life expectancy 6 months
compliance of the patient
written informed consent
Exclusion criteria
second neoplasia within the past 3 years except for non-melanotic skin cancer adequately treated Ca in situ of cervix uteri or adequately resected second colorectal cancer in patients with liver metastases of colorectal cancer
symptomatic extrahepatic disease in particular disseminated bone metastases brain metastases
liver cirrhosis with portal hypertension active hepatitis B or C previous percutaneous radiotherapy of the liver
active infection
history of gastric or duodenal ulcer
symptomatic or uncontrolled peripheral arterial occlusive disease history of stenosis of the renal artery
history of dilatative cardiomyopathy vitium of mitral or aortic valve persisting foramen ovale atrial fibrillation
artificial heart valve or vascular
history of diabetic microangiopathy
uncontrolled hyperthyriodism
other severe concomitant disease heart failure NYHA 2 respiratory failure renal failure stage2 liver failure TPZ 50
inherited or acquired immunodeficiency syndrome
contraindication against 5-FU
pregnancy and nursing no contraception
limited contractual capability
After enrollment an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules All regimens are based on 5-fluorouracil and leucovorin and optionally contain intraarterial mitomycin oxaliplatin or additional intravenous irinotecan
Patients are followed up and evaluated for primary and secondary endpoints After the inclusion of 50 patients treated and follow up at our institution the study population has been extended to 100 patients in 82004
histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation
non-resectable disease or hepatic resection or ablation in between the past 8 weeks
measurable disease at least before hepatic resection
Karnofsky performance status 70 or ECOG status 0-2
18 years of age
life expectancy 6 months
compliance of the patient
written informed consent
Exclusion criteria
second neoplasia within the past 3 years except for non-melanotic skin cancer adequately treated Ca in situ of cervix uteri or adequately resected second colorectal cancer in patients with liver metastases of colorectal cancer
symptomatic extrahepatic disease in particular disseminated bone metastases brain metastases
liver cirrhosis with portal hypertension active hepatitis B or C previous percutaneous radiotherapy of the liver
active infection
history of gastric or duodenal ulcer
symptomatic or uncontrolled peripheral arterial occlusive disease history of stenosis of the renal artery
history of dilatative cardiomyopathy vitium of mitral or aortic valve persisting foramen ovale atrial fibrillation
artificial heart valve or vascular
history of diabetic microangiopathy
uncontrolled hyperthyriodism
other severe concomitant disease heart failure NYHA 2 respiratory failure renal failure stage2 liver failure TPZ 50
inherited or acquired immunodeficiency syndrome
contraindication against 5-FU
pregnancy and nursing no contraception
limited contractual capability
After enrollment an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules All regimens are based on 5-fluorouracil and leucovorin and optionally contain intraarterial mitomycin oxaliplatin or additional intravenous irinotecan
Patients are followed up and evaluated for primary and secondary endpoints After the inclusion of 50 patients treated and follow up at our institution the study population has been extended to 100 patients in 82004
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