HAI Via Interventionally Implanted Port Catheter Systems
Primary Purpose
Colorectal Cancer, Liver Neoplasms, Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
interventionally implanted hepatic arterial port catheter
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal neoplasms, hepatocellular carcinoma, gallbladder cancer, bile duct cancer, hepatic arterial infusion
Eligibility Criteria
Inclusion Criteria: see above Exclusion Criteria: see above
Sites / Locations
- Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVKRecruiting
- Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität MagdeburgRecruiting
Outcomes
Primary Outcome Measures
Comparison of evaluation and intervention group
Complication rate (device implantation)
Safety of device and regional therapy
Secondary Outcome Measures
prospective evaluation of port duration
comparison of complication and port duration with an historical collective of patients provided with a surgically implanted hepatic arterial port catheter system (liver metastases of colorectal cancer)
response
progression free and overall survival
efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study
quality of life
Full Information
NCT ID
NCT00356161
First Posted
July 24, 2006
Last Updated
July 24, 2006
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00356161
Brief Title
HAI Via Interventionally Implanted Port Catheter Systems
Official Title
Open One-Arm Therapy Optimizing Trial on Regional Chemotherapy of the Liver Through an Interventionally Implanted A.Hepatica Port System in Patients With Liver Metastases or Primary Liver Neoplasms.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
5. Study Description
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 8/2004.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Neoplasms, Hepatocellular Carcinoma, Gallbladder Cancer, Bile Duct Cancer
Keywords
colorectal neoplasms, hepatocellular carcinoma, gallbladder cancer, bile duct cancer, hepatic arterial infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
interventionally implanted hepatic arterial port catheter
Primary Outcome Measure Information:
Title
Comparison of evaluation and intervention group
Title
Complication rate (device implantation)
Title
Safety of device and regional therapy
Secondary Outcome Measure Information:
Title
prospective evaluation of port duration
Title
comparison of complication and port duration with an historical collective of patients provided with a surgically implanted hepatic arterial port catheter system (liver metastases of colorectal cancer)
Title
response
Title
progression free and overall survival
Title
efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study
Title
quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
see above
Exclusion Criteria:
see above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bert Hildebrandt, MD
Phone
++49 30 450 553636
Email
bert.hildebrandt@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hanno Riess, MD, PhD
Phone
++49 30 450 553112
Email
hanno.riess@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert Hildebrandt, MD
Organizational Affiliation
Charté Centrum Tumormedizin, CVK, D-13344 Berlin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanno Riess, MD, PhD
Organizational Affiliation
Charité Centrum Tumormedizin, CVK, D-13344 Berlin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens Ricke, MD, PhD
Organizational Affiliation
Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roland Felix, MD, PhD
Organizational Affiliation
Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 Berlin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Neuhaus, MD, PhD
Organizational Affiliation
Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK
City
Berlin
ZIP/Postal Code
13344
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bert Hildebrandt, MD
Phone
++49 30 450 553 636
Email
bert.hildebrandt@charite.de
First Name & Middle Initial & Last Name & Degree
Annett Nicolaou, MD
Facility Name
Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Pech, MD
Phone
+49 391 67-13030
Email
radiologie@uni-magdeburg.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
15297586
Citation
Ricke J, Hildebrandt B, Miersch A, Nicolaou A, Warschewske G, Teichgraber U, Lopez Hanninen E, Riess H, Felix R. Hepatic arterial port systems for treatment of liver metastases: factors affecting patency and adverse events. J Vasc Interv Radiol. 2004 Aug;15(8):825-33. doi: 10.1097/01.RVI.0000136992.96374.60.
Results Reference
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HAI Via Interventionally Implanted Port Catheter Systems
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