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

NCT02936388 | Completed Phase 2 DMC

• 1 other identifier: SirTac2014
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveal Melanoma

Keywords

uveal melanoma; liver metastasis; chemoembolisation; radioembolisation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Arm A

EXPERIMENTAL

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

Procedure: SIRT

Arm B

ACTIVE COMPARATOR

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

Procedure: DSM-TACE

Interventions

SIRT PROCEDURE

catheter-based application of radioactive microspheres into the hepatic artery

Also known as: Drug: Yttrium-90 microspheres (SIR-Spheres®)

Arm A

DSM-TACE PROCEDURE

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

Also known as: Drug: Cisplatin and EmboCept®

Arm B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 12200, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Sirtuins; Cisplatin

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ulrich Keilholz, Prof. Dr. med.

  Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: October 18, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)