JPRN-jRCTs071180046已完成2 期
A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma - LOGIK1605/JART-1501
Fukuda Minoru0 个研究点目标入组 3 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
A phase 2 study of S-1/Cisplatin plus concurrent radiotherapy was conducted for locally advanced thymic carcinoma. Three cases were enrolled. One evaluable case was stable disease and had a response rate of 0%. The median progression-free survival, median overall survival, 1-, 2-, 3 years survival rates of 3 patients were 17.6 months, not reach, 100%, 67%, 67%, respectively. Two patients were not evaluable due to delayed start of the 2nd cycle of study treatment, but subsequently achieved complete remission
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Patients with thymic carcinoma confirmed histologically.
- •2. Patients without treatment history of chemotherapy,radiation
- •and surgical resection for thymic carcinoma.
- •3. Patients with unresectable locally advanced cancer and with
- •Masaoka stage classification, stage III. Eligible for only
- •metastasis to supraclavicular fossa or mediastinal lymph
- •node with Masaoka stage classification, stage IVb.
- •4. Patients who is judged that radical irradiation is possible by a
- •treatment plan of radiotherapist.
- •5. Patients without active double cancer.
- •6. Patient is at least 20 years of age (at enrollment date).
- •7. Performance status (ECOG): 0-1
- •8. The latest clinical laboratory test within 14 days prior to
- •enrollment (it is eligible on the same day 2 weeks before the
- •enrolment day) meets the following all standard.
- •1) WBC >= 3000/mm3 or neutrophil count >=1,500/mm3
- •2) Hemoglobin >= 9.0g/dL
- •3) Platelet count>= 100,000/mm3
- •4) AST, ALT < 100 IU/L
- •5) Total bilirubin <= 1.5mg/dL
- •6) Creatinine clearance >= 60 mL/min (Cockcroft-Gault
- •method, 24 hrs method)
- •7) PaO2 >= 60 Torr or SpO2 >= 90%
- •9. Patients providing the written informed consent.
- •10. Patients with life expectancy of at least 3 months.
排除标准
- •1. Patients who requires urgent radiation therapy with a symptom
- •of superior vena cava syndrome
- •2. Patients with serious complications : such as uncontrollable
- •angina pectoris, myocardial infarction within 3 months and
- •heart failure, uncontrollable diabetes mellitus,hypertension
- •and serious infection.
- •3. Patients with interstitial pneumonia confirmed by chest X-ray.
- •4. Patients having complications judged to affect the
- •enforcement of treatment.
- •5. Patients with anamnesis of severe hypersensitivity.
- •6. Patients with pregnant or possibly pregnant. Patients with
- •7. Patients who are different for the participation in the study by
- •complication of mental disease or psychiatric symptom.
- •8. Any other patients who are regarded as unsuitable for this
- •study by the investigators.
研究者
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