ISRCTN13366390已完成3 期
Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24332238
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with histologically confirmed adenocarcinoma of the stomach (including Siewert-Stein type II and III adenocarcinoma of the oesophago-gastric junction)
- •2. Age 18 years or older
- •3. Advanced disease not amenable to curative treatment
- •4. Documented progressive disease while receiving or within 6 months of completion of first line chemotherapy with a platinum and fluoropyrimidine based therapy either for advanced disease or as neoadjuvant/perioperative therapy
- •5. Estimated life expectancy greater than or equal to 12 weeks
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •7. Satisfactory haematologic (haemoglobin [Hb] greater than or equal to 10 g/dL, White Blood Cells [WBC] greater than or equal to 3.0 x 10^9/L, Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L, Platelets (Plt) greater than or equal to 100 x10^9/L), renal (creatinine less than or equal to Upper Limit of Normal [ULN]) and hepatic (total Bilirubin less than or equal to ULN, Alanine aminotransferase (ALT) less than or equal to 1.5 x ULN, Alkaline Phosphatase (ALP) less than or equal to 5 x ULN) function
- •8. Ability to give informed consent
- •9. Completion of baseline questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and EORTC-QLQ-STO22 [gastric cancer-specific QLQ] and EuroQoL (EQ-5D) questionnaire)
- •10. Patients of both sexes with reproductive potential must be willing to employ barrier contraceptives whilst on treatment and for 3 months after completion of treatment
排除标准
- •1. Cerebral or leptomeningeal metastasis
- •2. Prior chemotherapy with taxanes
- •3. Peripheral neuropathy
- •4. More than one prior chemotherapy regimen in advanced setting
- •5. Previous malignancy except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia
- •6. Pregnant or breastfeeding female patient
- •7. Any medical or psychiatric condition which would influence the ability to provide informed consent
- •8. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
研究者
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