EUCTR2008-008922-55-PT进行中（未招募）不适用
RANDOMIZED, OPEN, MULTICENTER, PROSPECTIVE, PHASE II CLINICAL TRIAL OF DOXORUBICIN vs. TRABECTEDIN PLUS DOXORUBICIN IN THE FIRST LINE TREATMENT OF PATIENTS WITH ADVANCED NON OPERABLE AND/OR METASTATIC SOFT TISSUE SARCOMAS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
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
- •The patient must sign voluntarily the informed consent
- •Aged between 18 and 70.
- •- Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.
- •- 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))
- •Mixofibrosarcoma
- •Epithelioid Sarcoma
- •Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid)
- •- Measurable disease, according to RECIST criteria
- •- Performance status 0-1 (ECOG).
- •- 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.
- •- Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.
- •- Normal cardiac function with a LVEF = 50% by echocardiogram or MUGA.
- •- It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If the patient is HCV+ it could be included in the study if there are no changes in transaminases values at investigators' discretion.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients presenting with any of the following criteria cannot be included in the study:
- •- Previous chemotherapy treatment.
- •- Previous radiotherapy involving the only localization(s) of measurable tumoral disease.
- •- Performance status = 2 (ECOG).
- •- CNS metastases.
- •- Plasma bilirubin > UNL.
- •- Creatinine > 1.6 mg/dL.
- •- History of other neoplastic disease with the exception of basalioma or in situ cervical cancer adequately treated.
- •- Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- •- Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 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
- •- Psychological, familial, social or geographic circumstances that limit the patient’s ability to comply with the protocol or informed consent.
- •- Patients participating in another clinical trial or receiving any other investigational product.
- •Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
- •- The following histologic subtypes are excluded:
- •- Rhabdomyosarcoma
- •-Ewing’s family of tumors
- •- Desmoplastic small round cell tumor
- •- Clear cell sarcoma
- •- Alveolar sarcoma
研究者
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