HAI Via Interventionally Implanted Port Catheter Systems
Recruitment status was: Recruiting
Bile Duct Cancer
Device: interventionally implanted hepatic arterial port catheter
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Comparison of evaluation and intervention group
- Complication rate (device implantation)
- Safety of device and regional therapy
- 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
- quality of life
|Study Start Date:||April 2002|
|Estimated Study Completion Date:||April 2008|
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356161
|Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK|
|Berlin, Germany, 13344|
|Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg|
|Magdeburg, Germany, 39120|
|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|