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

Primary Purpose

Uveal Melanoma

Status

Recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

SIRT

DSM-TACE

About this trial

This is an interventional treatment trial for Uveal Melanoma focused on measuring uveal melanoma, liver metastasis, chemoembolisation, radioembolisation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin FranklinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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

DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)

Outcomes

Primary Outcome Measures

Pregression-free survival (PFS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02936388

First Posted

September 9, 2016

Last Updated

November 8, 2021

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02936388

Brief Title

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

Acronym

SirTac

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 Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 2016 (undefined)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveal Melanoma

Keywords

uveal melanoma, liver metastasis, chemoembolisation, radioembolisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)

Intervention Type

Procedure

Intervention Name(s)

SIRT

Other Intervention Name(s)

Drug: Yttrium-90 microspheres (SIR-Spheres®)

Intervention Description

catheter-based application of radioactive microspheres into the hepatic artery

Intervention Type

Procedure

Intervention Name(s)

DSM-TACE

Other Intervention Name(s)

Drug: Cisplatin and EmboCept®

Intervention Description

catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Anna Peuker

Phone

+49 30 450 513470

caroline-anna.peuker@charite.de

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastian Ochsenreither, Dr. med.

sebastian.ochsenreither@charite.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrich Keilholz, Prof. Dr. med.

Organizational Affiliation

Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline Anna Peuker

Phone

+49 30 450 513470

caroline-anna.peuker@charite.de

First Name & Middle Initial & Last Name & Degree

Sebastian Ochsenreither

sebastian.ochsenreither@charite.de

12. IPD Sharing Statement

Plan to Share IPD

Yes

Links:

URL

https://cccc.charite.de/forschung/klinische_studien/solide_tumorerkrankungen/leber_und_gallentumore_icd10_c22_c24/

Description

Related Info

Learn more about this trial

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

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