Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

May 21, 2017 updated by: Michael Bernhard Pitton, Johannes Gutenberg University Mainz
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DEB TACE
Drug eluting Beads (DC Beads) loaded with Doxorubicin
Procedure: DEB TACE
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
Other Names:
  • Chemoembolisation
Experimental: SIRT
Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)
Procedure: SIRT
Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.
Other Names:
  • Radioembolisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: at the end of study
at the end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: at the end of study
at the end of study
Time to progression (TTP)
Time Frame: at the end of study
at the end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 16, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 21, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRT-TACE-CCC-Mainz-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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