JPRN-UMIN000005857已完成未知
Phase II Study to Evaluate Efficacy and Safety of Capecitabine + Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy - XParTS study
Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 40 人开始时间: 2011年6月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Forty patients (median age: 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months, which was longer than the 2-month protocol-specified threshold (p<0.001). Median OS was 13.7 months (95% CI, 9.0-17.7) and ORR was 8/30 (26.7%). Most common grade=>3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%). Conclusions: XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Positive HER2 status 2)Previous treatment with platinum agents 3)Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents 4)Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency 5)More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment. 6)Obvious infection or inflammation 7)Active hepatitis 8)Heart disease that is serious or requires hospitalization, or history of such disease within past year 9)Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis) 10)Being treated or in need of treatment with phenytoin or warfarin potassium 11)Chronic diarrhoea (watery stool or 4 times or more/day) 12)Active gastrointestinal haemorrhage 13)Body cavity fluids requiring drainage or other treatment 14)Clinical suspicion or previous history of metastases to brain or meninges 15)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16)Unwillingness to practice contraception 17)Poor oral intake 18)Psychiatric disorders which are being or may need to be treated with psychotropics 19)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
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