HAI Via Interventionally Implanted Port Catheter Systems

July 24, 2006 updated by: Charite University, Berlin, Germany

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13344
        • Recruiting
        • Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK
        • Contact:
        • Principal Investigator:
          • Annett Nicolaou, MD
      • Magdeburg, Germany, 39120
        • Recruiting
        • Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

see above

Exclusion Criteria:

see above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of evaluation and intervention group
Complication rate (device implantation)
Safety of device and regional therapy

Secondary Outcome Measures

Outcome Measure
quality of life
response
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)
progression free and overall survival
efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

April 1, 2008

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

July 25, 2006

Last Update Submitted That Met QC Criteria

July 24, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVK-HAI 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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