Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02936388

Studienbeginn:
Januar 2016

Letztes Update:
10.11.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Melanoma, Neoplasm Metastasis, Uveal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Studienleiter

Ulrich Keilholz, Prof. Dr. med.
Principal Investigator
Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)

Kontakt

Caroline Anna Peuker
Kontakt:
Phone: +49 30 450 513470
E-Mail: caroline-anna.peuker@charite.de» Kontaktdaten anzeigen

Sebastian Ochsenreither, Dr. med.
Kontakt:
E-Mail: sebastian.ochsenreither@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin
12200 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Caroline Anna Peuker
Phone: +49 30 450 513470
E-Mail: caroline-anna.peuker@charite.de

Sebastian Ochsenreither
E-Mail: sebastian.ochsenreither@charite.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This is a randomized phase II trial to evaluate the effect of transarterial radioembolisation

with yttrium-90 microspheres (SIRT) and transarterial chemoembolisation with cisplatin

(DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of

progression-free survival and multiple secondary endpoints.

Patients in study arm A will receive transarterial radioembolisation one time only. Patients

in study arm B will receive transarterial chemoembolisation every 4 to 6 weeks until complete

tumor devascularisation is observed or disease progression or intolerable toxicity occur. At

the time of local tumor progression patients will be offered the other treatment respectively

(either SIRT or DSM-TACE) as part of the study.

Ein-/Ausschlusskriterien

Inclusion Criteria (main):

- ECOG Performance Status of 0, 1 or 2

- Histologically or cytologically confirmed liver metastases of uveal melanoma

- At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if

contraindications against MRI exist CT with contrast media can is allowed)

- Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic

bone metastasis without indication for radiation)

- Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks

prior to study treatment start and recovery from toxicity is achieved

- Surgery in general and hepatic surgery in particular (e.g. lobe resection,

radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks

prior to study enrollment and recovery from surgery is achieved

Exclusion Criteria (main):

- Surgically treatable liver metastases

- Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation,

intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)

- Previous treatment with external liver radiation

- Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the

portal vein

- Liver cirrhosis Child-Pugh C

- Progressive liver failure

- Renale failure, bone marrow insufficiency, coagulopathy

- Uncontrolled or severe medical conditions which could impair the ability to

participate in the trial such as unstable cardiac disease or uncontrolled infection

- Other malignancy and/or metastases in need of treatment

- Current treatment with any anti-cancer therapy

Studien-Rationale

Primary outcome:

1. Pregression-free survival (PFS) (Time Frame - From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)

Studien-Arme

Experimental: Arm A
SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)
Active Comparator: Arm B
DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)

Geprüfte Regime

SIRT (Drug: Yttrium-90 microspheres (SIR-Spheres®)):
catheter-based application of radioactive microspheres into the hepatic artery
DSM-TACE (Drug: Cisplatin and EmboCept®):
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery

Quelle: ClinicalTrials.gov

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