EUCTR2009-014907-29-GB进行中（未招募）1 期
A prospective randomised controlled phase III trial of gemcitabine and docetaxel compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue sarcomas - GeDDiS
niversity College London0 个研究点目标入组 257 人开始时间: 2010年7月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 257
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
- •Locally advanced or metastatic soft tissue sarcoma, incurable by surgery or radiotherapy •Histological confirmation of high grade disease (Trojani grade 2 or 3 sarcoma) •Prior to trial enrolment, patients must have evidence of disease progression. Disease progression is defined as radiological progression when comparing current imaging to a prior disease assessment carried out within the previous 6 months. Some patients may present with evidence of clinical progression for whom there is concern regarding treatment delays incurred by awaiting radiological disease progression prior to trial entry – these cases must be discussed with the Chief Investigator to determine eligibility •No prior chemotherapy regimen for sarcoma and no prior doxorubicin containing regimen for any previously treated cancer •WHO performance status 0 – 2 •Age =13 years •Histological material available for central review (see section 8.7) •Measurable disease evaluable by RECIST criteria version 1.1. New lesions occurring in previously irradiated fields, and progression of previously irradiated lesions, will be eligible •Life expectancy of at least 3 months •Adequate organ function: Neutrophils =1.0 x 10*9/L Platelets =100 x 10*9/L Bilirubin =1.5 x upper limit of normal (ULN) AST or ALT =3.0 x ULN ALP =3.0 x ULN, if ALP = 3.0 x ULN, patients can be entered if this is shown to be bone isoenzyme Measured or calculated creatinine clearance =30 ml/min Ejection fraction (measured according to local practice) within normal limits for the site •Patients to agree to use contraception for the duration of the trial, where applicable (see section 5.3.3) •Able to complete quality of life questionnaires •Able to give informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Soft tissue sarcoma of the following types: Alveolar soft part sarcoma Gastrointestinal stromal tumour Ewing’s sarcoma family of tumours Alveolar or embryonal rhabdomyosarcoma Desmoplastic small round cell tumour Extra-skeletal myxoid chondrosarcoma Dermatofibrosarcoma protruberans Malignant mixed mesodermal tumour/carcinosarcoma of the uterus Smooth muscle tumours of uncertain malignant potential (STUMP) •Known active/uncontrolled brain metastases •Grade 3 or 4 peripheral neuropathy •Active uncontrolled infection •Prior history of malignancy other than sarcoma, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, breast or prostate, and unless the patient has been free of malignancy for a period of 3 years prior to first dose of trial drug •Women who are pregnant or lactating •Any serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or obtaining informed consent
研究者
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