JPRN-UMIN000010736已完成2 期
Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma - S-1 for thymic carcinoma
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital0 个研究点目标入组 26 人开始时间: 2013年5月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3-46.9) and an 80.8% disease control rate (90% CI, 65.4-90.3) in 25 pts. The median PFS was 4.3 months (95% CI, 2.3-10.3 months) and median OS was 27.4 months (95% CI, 16.6-34.3). Adverse events of greater than 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment related death was observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. With severe drug allergies for tegafur 2. With severe myleosuppression, renal disturbance, or liver disturbance 3. Current use of flucytosine 4. With severe uncontrolled systemic complication 5. Serious uncontrolled infections 6. With concrrent other malignant tumro 7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 8. With continuous diarrhea 9. With bowel paralysis or obstruction 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11.Symptomatic or uncontrolled brain metastasis 12. The patients treated with unapproved drugs within 30 days 13. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 14. Unable to intake orally
研究者
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