Hepatocellular CarcinomaPhase 2CEALNCT00807300
Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing CT-guided brachytherapy and transarterial chemoembolization in people with Hepatocellular Carcinoma, run by University of Magdeburg at 1 site in Germany.
Trial summary
Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CT-guided brachytherapy and transarterial chemoembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2015
- 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
- diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
- unresectable HCC
- Karnofsky-Index > 70
- estimated life expectancy > 16 weeks
- adequate bone marrow function
- adequate contraception for female patients
- informed consent
Who cannot join
- portal vein thrombosis on the tumor side
- extrahepatic spread
- Child C
- other untreated malignant disease
- general contraindication for chemotherapy
- active infectious disease
- neuropathy, platin-allergy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.
Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CT-guided brachytherapy, transarterial chemoembolization
- Keywords
- percutaneous treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided brachytherapyRadiation
catheter placed into the tumor by CT-guidance, radiation with iridium 192
transarterial chemoembolizationProcedure or surgery
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
| Study group | Role | What they receive |
|---|---|---|
| brachytherapy | Active comparator | Not described Receives: Radiation: CT-guided brachytherapy |
| TACE | Other | transarterial chemoembolization Receives: Procedure: transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to untreatable progression
Measured: the follow up period
Secondary outcomes (2)
Time to progression
Measured: the follow up period
Overall survival
Measured: the follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Ricke, University of Magdeburg
- Investigators
- Jens Ricke, M.D., Principal investigator, Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807300
- Sponsor's protocol ID
- 2005-000569-21
- Other IDs
- 2005
- Acronym
- CEAL
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT00807300
- Acronym / sponsor ID
- CEAL / 2005-000569-21
- Conditions
- Hepatocellular Carcinoma
- Keywords
- percutaneous treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Dec 2008 (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.
Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.
Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brachytherapy | Active comparator | Radiation: CT-guided brachytherapy |
| TACE | Other | Procedure: transarterial chemoembolizationtransarterial chemoembolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
- unresectable HCC
- Karnofsky-Index > 70
- estimated life expectancy > 16 weeks
- adequate bone marrow function
Key exclusion criteria (8 listed)
- portal vein thrombosis on the tumor side
- extrahepatic spread
- Child C
- other untreated malignant disease
- general contraindication for chemotherapy
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 |
|---|---|---|
| CT-guided brachytherapycatheter placed into the tumor by CT-guidance, radiation with iridium 192 | Radiation | brachytherapy |
| transarterial chemoembolizationapplication of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery | Procedure or surgery | TACE |
Primary outcome
Time to untreatable progression
Time frame: the follow up period
2 secondary outcomes
Time to progression
Time frame: the follow up period
Overall survival
Time frame: the follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Jens Ricke, M.D. principal investigator
Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-guided brachytherapy and transarterial chemoembolization in people with Hepatocellular Carcinoma, run by University of Magdeburg at 1 site 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to untreatable progression (time frame: the follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.