EUCTR2008-000570-21-IT进行中（未招募）不适用
Randomized phase II study of adjuvant chemotherapy with cisplatin + vinorelbine vs gemcitabine + vinorelbine in stage IB-IIIA radically resected non-small cell lung cancer (NSCLC) patients - MADS
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO0 个研究点开始时间: 2008年11月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent
- •2.Age > 18 years.
- •3.ECOG Performance status < 1
- •4.No evidence of important comorbidity
- •5.Radical resection (R0)
- •6.Pathological stage IB-IIA, IIIA (T3N1 only)
- •7.Histological diagnosis of non-small cell lung cancer (NSCLC)
- •8.No prior chemotherapy for NSCLC
- •9.Geographic proximity for an adequate follow-up
- •10.Baseline hematological examination assessed within 15 days prior to the enrollement, with the following values:
- •Hemoglobin > 10 gr/dl
- •ANC > 1.500/mm3
- •Platelets> 100.000/mm3
- •Bilirubin ≤ 2 x ULN
- •AST, ALT, alkaline phosphatase ≤ 3.0 x ULN
- •Creatinine < 1.5 x ULN
- •Creatinine clearance ≥ 60 ml/min
- •11.Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment.
- •12.No other malignant disease, with the exception of basocellular carcinoma of the skin,
- •adequately treated carcinoma in situ of the cervix, low-grade prostate cancer or other cancer
- •from which the patient has been disease-free for at least last three years.
- •13.No congestive heart failure or angina pectoris except if it is medically controlled. No previous history of myocardial infarction within 6 months prior to study entry, nor uncontrolled hypertension or arrhythmia.
- •14.No active (uncontrolled) infection requiring antibiotics.
- •15.No pre-existing motor or sensory neurotoxicity ≥ grade 2 (Common Terminology Criteria for Adverse Events, Version 3.0)
- •16.Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment
- •17.Before patient randomization, written informed consent will be obtained and documented according to ICH/GCP, and italian regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patient refusal
- •treatment not in the best interest of the patient, according to the responsible physician
- •excessive toxicity precluding further therapy, according to the responsible physician
- •treatment delay of more than 2 weeks
- •tumor progression
- •prior chemotherapy
研究者
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