EUCTR2006-003470-10-DE进行中（未招募）不适用
Randomised Phase II study with non-pegylated liposomal Doxorubicin (Myocet) plus Ifosfamid versus Doxorubicin plus Ifosfamid in the first-line treatment of locally advanced or metastatic soft tissue carcinoma. - LIDOXIF
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin0 个研究点开始时间: 2007年3月6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
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
- •-Signed written informed consent
- •-Male or female > 18 years of age
- •-Histologically confirmed locally advanced or metastatic soft tissue carcinoma
- •-At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present
- •-if of childbearing potential, willingness to use effective contraceptive methods and negative pregnancy
- •-male participants have to use effective contraceptive methods
- •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
- •-Signed written informed consent
- •-Male or female > 18 years of age
- •-Histologically confirmed locally advanced or metastatic soft tissue carcinoma
- •-At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present
- •-if of childbearing potential, willingness to use effective contraceptive methods and negative pregnancy
- •-male participants have to use effective contraceptive methods
- •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
- •-Other serious illness or medical conditions, Pregnancy or breast-feeding
- •-Unstable cardiac disease despite treatment,
- •-congestive heart failure NYHA grade 3 and 4; acute MI
- •-increased tendency to bleed
- •-known hypersensivity against ifosfamide or anthacylines
- •-pretreatment with anthracyclines up to the cumulative maximum dose
- •-missing written informed consent
- •-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- •-Having participated in another clinical trial or having received any investigational agent in the preceding 30 days
- •-Known allergic/hypersensitivity reaction to any of the components of the treatment
- •-Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding
- •-Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •-Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •-Lab results: leucocytes <3.0 x 109/L, platelets <80 x 109/L, bilirubin, SGOP,SGPT, AP >2x of the upper limit, creatinine > 1,5 mg/dl
- •-persons who are detained officially or legally to an official institute
- •- ECOG >2
- •-life-expectancy < 3month
- •-any chemotherapeutic treatment before participating in the CT
- •-histology: GIST, neurofibrosarcomas, fibrosarcomas, chondrosarcomas, highly differentiated sarcomas
- •-Other serious illness or medical conditions, Pregnancy or breast-feeding
- •-Unstable cardiac disease despite treatment,
- •-congestive heart failure NYHA grade 3 and 4; acute MI
- •-increased tendency to bleed
- •-known hypersensivity against ifosfamide or anthacylines
- •-pretreatment with anthracyclines up to the cumulative maximum dose
- •-missing written informed consent
- •-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- •-Having participated in another clinical trial or having received any investigational agent in the preceding 30 days
- •-Known allergic/hypersensitivity reaction to any of the components of the treatment
- •-Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding
- •-Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •-Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •-Lab results: leucocytes <3.0 x 109/L, platelets <80 x 109/L, bilirubin, SGOP,SGPT, AP >2x of the upper limit, creatinine > 1,5 mg/dl
- •-persons who are detained officially or legally to an official institute
- •- ECOG >2
- •-life-expectancy < 3month
- •-any chemotherapeutic treatment before participating in the CT
- •-histology: GIST, neurofibrosarcomas, fibrosarcomas, chondrosarcomas, highly differentiated sarcomas
研究者
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