The METROPHOLYS Study - Metronomic cyclophosphamide vs doxorubicin in elderly patients with advanced soft tissue sarcomas.Randomized, controlled open label clinical trial - The METROPHOLYS Study

ISTITUTO ONCOLOGICO VENETO - IRCCS0 个研究点目标入组 132 人开始时间: 2020年11月4日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•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

•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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