Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 46 for:    SIR-Spheres

Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis (SirTac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02936388
Recruitment Status : Unknown
Verified October 2016 by Caroline Anna Peuker, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Caroline Anna Peuker, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Procedure: SIRT Procedure: DSM-TACE Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Arm A
SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)
Procedure: SIRT
catheter-based application of radioactive microspheres into the hepatic artery
Other Name: Drug: Yttrium-90 microspheres (SIR-Spheres®)

Active Comparator: Arm B
DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)
Procedure: DSM-TACE
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery
Other Name: Drug: Cisplatin and EmboCept®




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936388


Contacts
Layout table for location contacts
Contact: Caroline Anna Peuker +49 30 450 513470 caroline-anna.peuker@charite.de
Contact: Sebastian Ochsenreither, Dr. med. sebastian.ochsenreither@charite.de

Locations
Layout table for location information
Germany
Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Caroline Anna Peuker    +49 30 450 513470    caroline-anna.peuker@charite.de   
Contact: Sebastian Ochsenreither       sebastian.ochsenreither@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Ulrich Keilholz, Prof. Dr. med. Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)

Additional Information:
Layout table for additonal information
Responsible Party: Caroline Anna Peuker, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02936388     History of Changes
Other Study ID Numbers: SirTac2014
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Caroline Anna Peuker, Charite University, Berlin, Germany:
uveal melanoma
liver metastasis
chemoembolisation
radioembolisation
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neoplasm Metastasis
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Cisplatin
Antineoplastic Agents