EUCTR2014-001549-26-ES进行中（未招募）不适用
Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus Radiotherapy in Soft Tissue Sarcoma patients.
GEIS0 个研究点目标入组 96 人开始时间: 2014年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria Cohort A
- •-Aged between 18 and 70.
- •-Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metatasectomy or surgery resection or not oncologically recommended metastasectomy
- •-Patients must have documentation of disease progression within 6 months prior to study entry.
- •-The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed as long as trabectedin has not been included.
- •-The following histological subtypes can be included:
- •+Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma)
- •+Leiomyosarcoma
- •+Angiosarcoma/ epithelial hemangioendothelioma
- •+Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic)
- •+Synovial sarcoma
- •+Fibrosarcoma and its variants (epithelial fibrosarcoma/low grade fibromyxoid sarcoma)
- •+Hemangiopericytoma/solitary fibroid tumor
- •+Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST)
- •+Myxofibrosarcoma
- •+Epithelioid Sarcoma
- •+Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid)
- •+Measurable disease, according to RECIST V 1.1 criteria
- •+Adequate respiratory functions: FEV1 >1L
- •-Adequate bone marrow function (hemoglobin > 10 g/dl, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dl, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL.
- •-Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA.
- •-Disease distribution in lungs allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point.
- •- Patient must have a Central Venous Catheter for treatment
- •-Aged between 18 and 70.
- •-Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm.
- •-Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.
- •-Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point.
- •-Measurable disease, according to RECIST V 1.1 criteria
- •-Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dL, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL.
- •-Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA.
- •-Patient may have had one previous chemotherapy line.
- •-Patient must have a Central Venous Catheter for treatment.
- •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 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Previous treatment with trabectedin or radiotherapy involving any lung field.
- •-Performance status ? 2 (ECOG).
- •-Metastases out of those located in lungs.
- •-Plasma bilirubin > UNL.
- •-Creatinine > 1.6 mg/dL.
- •-History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
- •-Severe COPD or other severe pulmonary diseases.
- •-Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- •-Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
- •-Uncontrolled bacterial, mycotic or viral infections.
- •-Known positive test for infection by human immunodeficiency virus (HIV).
- •-Women who are pregnant or breast-feeding.
- •1.More than one previous chemotherapy treatment for local disease including trabectedin.
- •2.Radiotherapy involving the tumoral bed.
- •3.Performance status ? 2 (ECOG).
- •4.Presence of metastases or lymph node involvement by the tumor.
- •5.Location other than limb or superficial trunk wall.
- •6.Plasma bilirubin > UNL.
- •7.Creatinine > 1.6 mg/dL.
- •8.History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
- •9.Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- •10.Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
- •11.Uncontrolled bacterial, mycotic or viral infections.
- •12.Known positive test for infection by human immunodeficiency virus (HIV).
- •13.Women who are pregnant or breast-feeding.
- •14.Psychological, familial, social or geographic circumstances that limit the patient?s ability to comply with the protocol or informed consent.
- •15.Patients participating in another clinical trial or receiving any other investigational product.
- •16.Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
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