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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT01798147

Studienbeginn:
Februar 2011

Letztes Update:
23.05.2017

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Cholangiocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Johannes Gutenberg University Mainz

Collaborator:
-

Kontakt

Roman Kloeckner, MD
Kontakt:
Phone: ++49613117
Phone (ext.): 2019
E-Mail: roman.kloeckner@unimedizin-mainz.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Diagnostic and Interventional Radiology
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Roman Kloeckner, MD
Phone: ++49613117
Phone (ext.): 2019
E-Mail: roman.kloeckner@unimedizin-mainz.de
» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) (Time Frame - at the end of study)



Secondary outcome:

1. Overall survival (OS) (Time Frame - at the end of study)

2. Time to progression (TTP) (Time Frame - at the end of study)

Studien-Arme

  • Active Comparator: DEB TACE
    Drug eluting Beads (DC Beads) loaded with Doxorubicin
  • Experimental: SIRT
    Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)

Geprüfte Regime

  • DEB TACE (Chemoembolisation):
    DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
  • SIRT (Radioembolisation):
    Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.

Quelle: ClinicalTrials.gov


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