EUCTR2018-001075-20-IT进行中（未招募）1 期
The METROPHOLYS Study - Metronomic cyclophosphamide vs doxorubicin in elderly patients with advanced soft tissue sarcomas.Randomized, controlled open label clinical trial - The METROPHOLYS Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
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
- •Patients may be included in the study only if they meet all the following criteria:
- •1-Histologically proven diagnosis of soft tissue sarcoma.
- •2-Advanced unresectable or metastatic soft tissue sarcoma not previously treated with chemotherapy for metastatic disease.
- •3-At least one measurable lesion according to RECIST1.1 criteria.
- •4-Availability of a tumor sample
- •5-Age = 70 years
- •6-ECOG PS 0-2.
- •7-Life expectancy of at least 12 weeks.
- •8-Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl.
- •9-Normal hepatic, renal anf cardiac function.
- •10- Male subjects with female partners of childbearing potential must be willing to use adequate contraception.
- •11- Geriatric assessment by means of G8 screening tool and CRASH score.
- •12- Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 132
排除标准
- •Patients will be excluded from the study for any of the following reasons:
- •1-Previous treatment for metastatic disease.
- •2-Previous (neo) adjuvant chemotherapy with anthracyclines.
- •3-Radiotherapy to any site within 4 weeks before the study.
- •4-Untreated brain metastases or spinal cord compression or primary brain tumors.
- •5-Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration.
- •6-Clinically significant cardiovascular disease
- •7-Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer)
- •8-Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
- •9-Lack of physical integrity of the upper gastrointestinal tract, .
- •10- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
- •11- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
- •12- Sexually active males unwilling to practice contraception
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