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

Uveal Melanoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936388
• Other study ID #: SirTac2014
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Charite University, Berlin, Germany
• Contact: Caroline Anna Peuker
• Phone: +49 30 450 513470
• Email: caroline-anna.peuker[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Neoplasm Metastasis
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Procedure:
• SIRT
catheter-based application of radioactive microspheres into the hepatic artery
• DSM-TACE
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

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