Colorectal CancerPhase 2NCT00356161
HAI Via Interventionally Implanted Port Catheter Systems
A Phase 2 study testing interventionally implanted hepatic arterial port catheter in people with Colorectal Cancer and Liver Neoplasms, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Neoplasms, Hepatocellular Carcinoma
- What is being tested?
- interventionally implanted hepatic arterial port catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2002to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- see above
Who cannot join
- see above
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK
Berlin, 13344
Bert Hildebrandt, MD, ++49 30 450 553 636, bert.hildebrandt@charite.de
Annett Nicolaou, MD
- Recruiting
Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg
Magdeburg, 39120
Maciej Pech, MD, +49 391 67-13030, radiologie@uni-magdeburg.de
About this study
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.
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.
Read the 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.
- Conditions
- Colorectal Cancer, Liver Neoplasms, Hepatocellular Carcinoma, Gallbladder Cancer, Bile Duct Cancer
- Being tested
- interventionally implanted hepatic arterial port catheter
- Keywords
- colorectal neoplasms, hepatocellular carcinoma, gallbladder cancer, bile duct cancer, hepatic arterial infusion
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular, Gallbladder Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionally implanted hepatic arterial port catheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startApr 2002
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Bert Hildebrandt, MD, Study chair, Charté Centrum Tumormedizin, CVK, D-13344 BerlinHanno Riess, MD, PhD, Study chair, Charité Centrum Tumormedizin, CVK, D-13344 BerlinJens Ricke, MD, PhD, Study chair, Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 MagdeburgRoland Felix, MD, PhD, Study chair, Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 BerlinPeter Neuhaus, MD, PhD, Study chair, Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356161
- Sponsor's protocol ID
- CVK-HAI 1
- Status last verified
- Jul 2006
- First submitted
- 24 Jul 2006
- Last updated
- 25 Jul 2006
- Results posted
- No
Publications
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.
PubMed 15297586
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00356161
- Acronym / sponsor ID
- CVK-HAI 1
- Conditions
- Colorectal Cancer, Liver Neoplasms, Hepatocellular Carcinoma, Gallbladder Cancer, Bile Duct Cancer
- Keywords
- colorectal neoplasms, hepatocellular carcinoma, gallbladder cancer, bile duct cancer, hepatic arterial infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Apr 2008
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- see above
Key exclusion criteria (1 listed)
- see above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventionally implanted hepatic arterial port catheter | Device | – |
Primary outcome
Comparison of evaluation and intervention group
Complication rate (device implantation)
Safety of device and regional therapy
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2006.
- Background: PubMed 15297586Ricke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Hildebrandt, MD study chair
Charté Centrum Tumormedizin, CVK, D-13344 Berlin
Hanno Riess, MD, PhD study chair
Charité Centrum Tumormedizin, CVK, D-13344 Berlin
Jens Ricke, MD, PhD study chair
Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interventionally implanted hepatic arterial port catheter in people with Colorectal Cancer and Liver Neoplasms, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bert Hildebrandt, MD (++49 30 450 553636, bert.hildebrandt@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of evaluation and intervention group. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2006.