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

niversity College London (UCL) (UK)0 个研究点目标入组 250 人开始时间: 2009年9月11日最近更新: 2022年2月7日

适应症

试验速览

•1. Locally advanced or metastatic soft tissue sarcoma, incurable by surgery or radiotherapy
•2. Evidence of disease progression in the 6 weeks prior to trial entry
•3. No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant therapy is allowed
•4. World Health Organization (WHO) performance status 0 - 2
•5. Aged greater or equal to 13 years, either sex
•6. Histologically confirmed soft tissue sarcoma excluding: alveolar soft part sarcoma, gastrointestinal stromal tumour, Ewing's sarcoma family of tumours, rhabdomyosarcoma
•7. Desmoplastic small round cell tumour, extra-skeletal myxoid chondrosarcoma
•8. Histological material available for central review
•9. Measurable disease evaluable by Response Evaluation Criteria In Solid Tumours (RECIST) criteria
•10. Life expectancy of at least 3 months
•11. Adequate organ function:
•11.1. Neutrophils greater than 1.5
•11.2. Platelets greater than 100
•11.3. Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
•11.4. Aspartate aminotransferase (AST) less than or equal to 3 x ULN
•11.5. Serum creatinine less than or equal to 1.5 x ULN; measured creatinine clearance greater or equal to 50 ml/min
•12. Ejection fraction as assessed by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO) greater than or equal to 50%

•1. Known active central nervous system (CNS) metastases
•2. Grade 3 or 4 peripheral neuropathy
•3. Pregnancy or lactating
•4. Active uncontrolled infection including known a history of acquired immune deficiency syndrome (AIDS)
•5. Patients with previous non-sarcomatous malignancy should not have detectable disease and must not be on active treatment for the disease
•6. Any serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or obtaining informed consent

发起方

niversity College London (UCL) (UK)