Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin
关键词
抽象
日期
| 最后验证: | 06/30/2019 |
| 首次提交: | 11/09/2014 |
| 提交的预估入学人数: | 02/03/2015 |
| 首次发布: | 02/09/2015 |
| 上次提交的更新: | 07/10/2019 |
| 最近更新发布: | 07/14/2019 |
| 实际学习开始日期: | 12/31/2014 |
| 预计主要完成日期: | 06/30/2022 |
| 预计完成日期: | 06/30/2022 |
状况或疾病
干预/治疗
Drug: Trabectedin
Genetic: DNA double-strand breaks
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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). | |
| Active Comparator: Trabectedin Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Progression-free Survival (PFS) [planned after 46 events after start of recruitment which are expected to occur after 27 month]
次要成果指标
1. Radiological response according to RECIST [planned after 46 events after start of recruitment which are expected to occur after 27 month]
2. Overall Survival (OS) [planned after 46 events after start of recruitment which are expected to occur after 27 month]
3. Treatment related toxicity (hematological, renal, hepatic, others) [planned after 46 events after start of recruitment which are expected to occur after 27 month]
