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HAI Via Interventionally Implanted Port Catheter Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356161
Recruitment Status : Unknown
Verified July 2006 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : July 25, 2006
Last Update Posted : July 25, 2006
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE July 24, 2006
First Posted Date  ICMJE July 25, 2006
Last Update Posted Date July 25, 2006
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • Comparison of evaluation and intervention group
  • Complication rate (device implantation)
  • Safety of device and regional therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE HAI Via Interventionally Implanted Port Catheter Systems
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Liver Neoplasms
  • Hepatocellular Carcinoma
  • Gallbladder Cancer
  • Bile Duct Cancer
Intervention  ICMJE Device: interventionally implanted hepatic arterial port catheter
Study Arms  ICMJE Not Provided
Publications * Ricke J, Hildebrandt B, Miersch A, Nicolaou A, Warschewske G, Teichgräber U, Lopez Hänninen 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: July 24, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

see above

Exclusion Criteria:

see above

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00356161
Other Study ID Numbers  ICMJE CVK-HAI 1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bert Hildebrandt, MD Charté Centrum Tumormedizin, CVK, D-13344 Berlin
Study Chair: Hanno Riess, MD, PhD Charité Centrum Tumormedizin, CVK, D-13344 Berlin
Study Chair: Jens Ricke, MD, PhD Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg
Study Chair: Roland Felix, MD, PhD Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 Berlin
Study Chair: Peter Neuhaus, MD, PhD Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin
PRS Account Charite University, Berlin, Germany
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP