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

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Brief Title

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

Official Title

A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma

Brief Summary

      Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver
      metastases in patients with advanced uveal melanoma with respect to progression-free survival
      and exploratory comparison of secondary endpoints regarding application, activity, adverse
      effects and impact on quality of life in a randomized study design.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Pregression-free survival (PFS)


Condition

Uveal Melanoma

Intervention

SIRT

Study Arms / Comparison Groups

 Arm A
Description:  SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

108

Start Date

January 2016

Completion Date

December 2021

Primary Completion Date

January 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Ulrich Keilholz, Prof. Dr. med., +49 30 450 513470, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02936388

Organization ID

SirTac2014


Responsible Party

Principal Investigator

Study Sponsor

Charite University, Berlin, Germany


Study Sponsor

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


Verification Date

November 2019