Intrahepatic Cholangiocellular CarcinomaPhase 2NCT01798147
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
A Phase 2 study testing DEB TACE and SIRT in people with Intrahepatic Cholangiocellular Carcinoma, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocellular Carcinoma
- What is being tested?
- DEB TACE and SIRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jun 2018
- 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
- ≥18 years
- Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
- Tumor confined to the liver
- At least one measurable lesion in magnetic resonance imaging (MRI)
- Tumor load ≤ 50%
- Preserved liver function (Child Pugh A and B)
- ECOG performance status ≤2
Who cannot join
- Patients feasible for curative treatment (e.g. resection or local ablation)
- Previous TACE or SIRT
- Prior Chemotherapy
- Child Pugh stage C
- ECOG Performance Status >1
- Tumor involvement >50% of the liver
Show all 17Show fewer
- Extrahepatic tumor
- Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
- Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
- Esophageal bleeding during the last 3 months
- Hepatic encephalopathy
- Transjugular intrahepatic portosystemic shunt (TIPS)
- Infiltration or occlusion of the main portal vein
- Hepatofugal blood flow in the portal vein
- Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
- Contraindications against angiography
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Diagnostic and Interventional Radiology
Mainz, 55131
Roman Kloeckner, MD, ++49613117 ext. 2019, roman.kloeckner@unimedizin-mainz.de
About this study
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
- Conditions
- Intrahepatic Cholangiocellular Carcinoma
- Being tested
- DEB TACE, SIRT
- Keywords
- Cholangiocellular Carcinoma, TACE, SIRT
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB TACEProcedure or surgery
Also called Chemoembolisation
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
SIRTProcedure or surgery
Also called Radioembolisation
Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.
| Study group | Role | What they receive |
|---|---|---|
| DEB TACE | Active comparator | Drug eluting Beads (DC Beads) loaded with Doxorubicin Receives: Procedure: DEB TACE |
| SIRT | Experimental | Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres) Receives: Procedure: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: at the end of study
Secondary outcomes (2)
Overall survival (OS)
Measured: at the end of study
Time to progression (TTP)
Measured: at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2011
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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 Intrahepatic Cholangiocellular 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bernhard Pitton, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798147
- Sponsor's protocol ID
- SIRT-TACE-CCC-Mainz-1
- Status last verified
- May 2017
- First submitted
- 16 Feb 2013
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kloeckner R, Ruckes C, Kronfeld K, Worns MA, Weinmann A, Galle PR, Lang H, Otto G, Eichhorn W, Schreckenberger M, Dueber C, Pitton MB. Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial. Trials. 2014 Aug 6;15:311. doi: 10.1186/1745-6215-15-311.
PubMed 25095718
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
- ClinicalTrials.gov ID
- NCT01798147
- Acronym / sponsor ID
- SIRT-TACE-CCC-Mainz-1
- Conditions
- Intrahepatic Cholangiocellular Carcinoma
- Keywords
- Cholangiocellular Carcinoma, TACE, SIRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Feb 2013 (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.
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB TACE | Active comparator | Procedure: DEB TACEDrug eluting Beads (DC Beads) loaded with Doxorubicin |
| SIRT | Experimental | Procedure: SIRTSelective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years
- Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
- Tumor confined to the liver
- At least one measurable lesion in magnetic resonance imaging (MRI)
- Tumor load ≤ 50%
Key exclusion criteria (17 listed)
- Patients feasible for curative treatment (e.g. resection or local ablation)
- Previous TACE or SIRT
- Prior Chemotherapy
- Child Pugh stage C
- ECOG Performance Status >1
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 |
|---|---|---|
| DEB TACEAlso: ChemoembolisationDEB TACE every 6 weeks until either no viable tumor or endpoint reached. | Procedure or surgery | DEB TACE |
| SIRTAlso: RadioembolisationSelective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint. | Procedure or surgery | SIRT |
Primary outcome
Progression-free survival (PFS)
Time frame: at the end of study
2 secondary outcomes
Overall survival (OS)
Time frame: at the end of study
Time to progression (TTP)
Time frame: at the end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 25095718Kloeckner R, Ruckes C, Kronfeld K, Worns MA, Weinmann A, Galle PR, Lang H, Otto G, Eichhorn W, Schreckenberger M, Dueber C, Pitton MB. Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial. Trials. 2014 Aug 6;15:311. doi: 10.1186/1745-6215-15-311.
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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.
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 DEB TACE and SIRT in people with Intrahepatic Cholangiocellular Carcinoma, run by Johannes Gutenberg University Mainz 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 17 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 23 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Kloeckner, MD (++49613117 ext. 2019, roman.kloeckner@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: at the end of study). 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 NCT01798147, 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 23 May 2017.