Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
- •Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT
- •Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
- •After macroscopic incomplete resection or marginal resection (tumor-free margins < 1 cm)
- •Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines
- •At least one tumor manifestation which is eligible for hyperthermia
- •Performance status (ECOG) 0,1 or 2
- •More than 3 weeks from last treatment
- •Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l
- •Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN
- •Patients with the ability to follow study instructions and likely to attend and complete all required visits
- •Written informed consent of the subject
排除标准
- •Uncontrolled infection (e.g. active viral hepatitis)
- •Unstable cardiac status
- •Peripheral neuropathy > grade 2
- •Known or persistent abuse of medications, drugs or alcohol
- •Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
- •Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure
- •Pregnancy or breast-feeding
- •Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration
- •Uncontrolled CNS-metastases
- •Medical or technical impossibility for hyperthermia to heat the major target lesion
研究组 & 干预措施
Trabectedin with regional hyperthermia
Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs).
干预措施: Trabectedin (Drug)
Trabectedin with regional hyperthermia
Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs).
干预措施: DNA double-strand breaks (Genetic)
Trabectedin
Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
干预措施: Trabectedin (Drug)
Trabectedin
Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
干预措施: DNA double-strand breaks (Genetic)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: planned after 46 events after start of recruitment which are expected to occur after 27 month
次要结局
- Treatment related toxicity (hematological, renal, hepatic, others)(planned after 46 events after start of recruitment which are expected to occur after 27 month)
- Radiological response according to RECIST(planned after 46 events after start of recruitment which are expected to occur after 27 month)
- Overall Survival (OS)(planned after 46 events after start of recruitment which are expected to occur after 27 month)
研究者
Eric Kampmann
Dr. med.
Ludwig-Maximilians - University of Munich