HAI Via Interventionally Implanted Port Catheter Systems
NCT ID: NCT00356161
Last Updated: 2006-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2002-04-30
2008-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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interventionally implanted hepatic arterial port catheter
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Principal Investigators
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Bert Hildebrandt, MD
Role: STUDY_CHAIR
Charté Centrum Tumormedizin, CVK, D-13344 Berlin
Hanno Riess, MD, PhD
Role: STUDY_CHAIR
Charité Centrum Tumormedizin, CVK, D-13344 Berlin
Jens Ricke, MD, PhD
Role: STUDY_CHAIR
Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg
Roland Felix, MD, PhD
Role: STUDY_CHAIR
Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 Berlin
Peter Neuhaus, MD, PhD
Role: STUDY_CHAIR
Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin
Locations
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Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK
Berlin, , Germany
Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg
Magdeburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Bert Hildebrandt, MD
Role: primary
Maciej Pech, MD
Role: primary
References
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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.
Other Identifiers
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CVK-HAI 1
Identifier Type: -
Identifier Source: org_study_id