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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT02936388

Collaborator

(none)

108

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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 Names: 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 Names: Drug: Cisplatin and EmboCept®

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 Names:

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 Names:

Drug: Cisplatin and EmboCept®

Outcome Measures

Primary Outcome Measures

Pregression-free survival (PFS) [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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