JPRN-UMIN000009345已完成2 期
Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202) - Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)
Okayama Lung Cancer Study Group0 个研究点目标入组 32 人开始时间: 2012年11月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
Carboplatin plus S-1 had favorable efficacy and tolerable toxicity for the elderly with NSCLC. This study met the predesigned primary endpoint, and the regimen seems to be a potent treatment option. Low TP expression in tumors might serve as a predictive maker of a better DCR. We need to conduct further studies to evaluate whether this combination is superior to the standard first-line treatment for the elderly.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 70years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with brain metastases with the clinical symptoms 2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity 3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion) 4) Patients with a history of severe drug allergy 5) Pregnancy, breast feeding or wish of future bearing 6) Patients with severe complication Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months) Uncontrollable diabetes mellitus Patients with severe infection Patients has pleural effusion, pericardial effusion and ascites to be treated 7) Patients who need to be treated by radiotherapy in an urgent 8) concomitant therapy with other pyrimidine fluoride antineoplastic agents 9) concomitant therapy with warfarin 10) concomitant therapy with dabigatran etexilate 11) Principal investigator cases that are deemed inappropriate
研究者
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