Randomized Phase II Trial of SIRT and TACE in Liver Metastases of Uveal Melanoma

• Conditions: iver Metastases from Uveal Melanoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002439-32-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-13
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male or female patients = 18 years of age
•ECOG PS 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)
•Life expectancy > 3 months
•Signed informed consent
•The following laboratory parameters must be met at time of inclusion:
oTotal bilirubin < 3x ULN
oNeutrophil granulocytes = 1.0/nl
oLeucocytes = 2.5/nl
oPlatelets = 100/nl
oHaemoglobin = 9 g/dl
oSerum creatinine < 1.5 mg/dl
oaPTT = 50 sec.
oProthrombine time (PT) = 70%
oSerum albumine = 28 g/l
oSGOT, SGPT < 2x ULN
•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
•Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatment and must be willing to use adequate methods of contraception (pearl index < 1) during the study and for 3 months after last study drug administration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Surgically treatable liver metastases
Previous intraarterial hepatic treatment (e.g. radioemolization, chemoembolization, 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
Other malignancy and/or metastases in need of treatment
Current treatment with any anti-cancer therapy
One of the following existing medical conditions:
o Unstable cardiac disease despite treatment, congestive heart failure NYHA grade > II, malignant cardiac arrhythmia
o Significant neurologic or psychiatric disorders including dementia
o Active uncontrolled infection
o Active disseminated intravascular coagulation
o Active bleeding diathesis or patients on oral anti-vitamin-K medication or comparable coagulation influencing medication (such as thrombin inhibitors as dabigatran or direct Factor Xa inhibitors as rivaroxaban or apixaban)
o Known history of HIV seropositivity or Hepatitis B or C infection
o Any other severe and/or uncontrolled medical conditions which could impair the ability of the patient to participate in the study
• Pregnancy (absence confirmed by serum ß-HCG test) or breast-feeding
• Known allergic reactions or hypersensitivity to any of the components of the treatment
• Legal incapacity or limited legal capacity or existing medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or to sign meaningful informed consent
• Accommodation in an institution under officially or judicially orders (§40 p.1 No. 4 AMG)
• Participation in an interventional study in the last 30 days before inclusion in this trial
• Employees of the study site are excluded from participation in the trial (§40 subparagraph 1 No. 3b AMG)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This is a randomized phase II trial to evaluate the relative efficacy of transarterial radioembolization with yttrium-90 microspheres (SIRT) in comparison to standard treatment with transarterial chemoembolization with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival. ;Secondary Objective: To compare quality of life during treatment and feasibility of the two treatment options.;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: Every 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Hepatic response (CR + PR) <br>•Toxicity <br>•Disease control (PR + CR + SD)<br>•Hepatic progression-free survival (PFS-L)<br>•Overall survival (OS)<br>•Quality of Life (QoL)<br>;Timepoint(s) of evaluation of this end point: Interrim analysis after 20 patients have been accrued to each study arm and final analysis after inclusion of 45 patients in each study arm (total of 90 patients).