COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophago-gastric adenocarcinoma - COUGAR-02

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 168 人开始时间: 2007年11月7日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•-Age >18 years -Histologically confirmed adenocarcinoma of the oesophagus or stomach (including adenocarcinoma of the oesophago-gastric junction) -Advanced disease not amenable to curative treatment -Documented progressive disease while receiving or within 6 months of completion of chemotherapy with a platinum and fluoropyrimidine or raltitrexed based therapy -Estimated life expectancy of at least 12 weeks -ECOG performance status 0,1 or 2 -Satisfactory hematological (Hb >10g/dL, WBC > 3.0 x 10 9/L, ANC > 1.5 x 10 9/L, Plt >100 x 10 9/L), renal (creatinine < ULN, or measured/calculated Creatinine clearance > 60ml/min) and hepatic (TBR < ULN, ALT < 1.5 x ULN, ALP < 5 x ULN) function -Ability to give informed consent -Completion of baseline QoL questionnaires (QLQ-C30,STO22 & EQ-5D) -Patients of both sexes with reproductive potential must employ barrier contraceptives whilst on treatment and for 3 months following completion of treatment
•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

•-Cerebral or leptomeningeal metastasis -Prior chemotherapy with taxanes -Clinically significant peripheral neuropathy (Grade 2 to Grade 4) which in the view of the Investigator would be a contraindication to taxane therapy. -Previous malignancy within the 5 years prior trial entry except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia -Pregnant or lactating females

发起方