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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pregression-free survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A
SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)
干预措施: SIRT (Procedure)
Arm B
DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)
干预措施: DSM-TACE (Procedure)
结局指标
主要结局
Pregression-free survival (PFS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Caroline Anna Peuker
MD
Charite University, Berlin, Germany