HAI Via Interventionally Implanted Port Catheter Systems
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Charite University, Berlin, Germany.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Charite University, Berlin, Germany
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00356161
First received: July 24, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Liver Neoplasms Hepatocellular Carcinoma Gallbladder Cancer Bile Duct Cancer |
Device: interventionally implanted hepatic arterial port catheter |
Phase 2 |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Comparison of evaluation and intervention group
- Complication rate (device implantation)
- Safety of device and regional therapy
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | April 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
see above
Exclusion Criteria:
see above
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356161
Contacts
| Contact: Bert Hildebrandt, MD | ++49 30 450 553636 | bert.hildebrandt@charite.de |
| Contact: Hanno Riess, MD, PhD | ++49 30 450 553112 | hanno.riess@charite.de |
Locations
| Germany | |
| Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK | Recruiting |
| Berlin, Germany, 13344 | |
| Contact: Bert Hildebrandt, MD ++49 30 450 553 636 bert.hildebrandt@charite.de | |
| Principal Investigator: Annett Nicolaou, MD | |
| Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg | Recruiting |
| Magdeburg, Germany, 39120 | |
| Contact: Maciej Pech, MD +49 391 67-13030 radiologie@uni-magdeburg.de | |
Sponsors and Collaborators
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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00356161 History of Changes |
| Other Study ID Numbers: | CVK-HAI 1 |
| Study First Received: | July 24, 2006 |
| Last Updated: | July 24, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
colorectal neoplasms hepatocellular carcinoma gallbladder cancer bile duct cancer hepatic arterial infusion |
Additional relevant MeSH terms:
|
Gallbladder Neoplasms Neoplasms Carcinoma Colorectal Neoplasms Liver Neoplasms Bile Duct Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Liver Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Bile Duct Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 21, 2013