NCT00356161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 25, 2006

Status Verified

July 1, 2006

First QC Date

July 24, 2006

Last Update Submit

July 24, 2006

Conditions

Colorectal CancerLiver NeoplasmsHepatocellular CarcinomaGallbladder CancerBile Duct Cancer

Keywords

colorectal neoplasmshepatocellular carcinomagallbladder cancerbile duct cancerhepatic arterial infusion

Outcome Measures

Primary Outcomes (3)

  • Comparison of evaluation and intervention group

  • Complication rate (device implantation)

  • Safety of device and regional therapy

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

interventionally implanted hepatic arterial port catheterDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • see above

You may not qualify if:

  • see above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK

Berlin, 13344, Germany

RECRUITING

Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15297586BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsLiver NeoplasmsCarcinoma, HepatocellularGallbladder NeoplasmsBile Duct Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct Diseases

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Bert Hildebrandt, MD

CONTACT

++49 30 450 553636bert.hildebrandt@charite.de

Hanno Riess, MD, PhD

CONTACT

++49 30 450 553112hanno.riess@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

April 1, 2002

Study Completion

April 1, 2008

Last Updated

July 25, 2006

Record last verified: 2006-07

Locations

DE(2)