EUCTR2005-003822-25-BE进行中（未招募）不适用
Randomized Phase II Study Of Pemetrexed And Cisplatin As Either Induction or Adjuvant Chemotherapy In Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 140 人开始时间: 2006年3月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •? Pathological proven NSCLC.
- •? Performance status: WHO = 2.
- •? Age > 18 years.
- •? Clinical stage IB-II NSCLC: cT2N0M0, cT1N1M0, cT2N1M0 or cT3N0M0.
- •? No evidence of mediastinal involvement as assessed by either mediastinoscopy and/or FDGPET scan.
- •? No evidence of metastatic disease as assessed by routine dissemination analysis according to institutional practice.
- •? Tumor considered resectable by multidisciplinary team.
- •? Presence of at least one measurable lesion (using RECIST criteria)
- •? No prior therapy for NSCLC (chemotherapy, radiotherapy or surgery).
- •? Adequate hematological function:
- •? ANC > 1.5 x 109/L
- •? Platelets> 100 x 109/L
- •? Hemoglobin > 10 g/dl (6,2 mmol/l)
- •? Adequate renal function:
- •? calculated creatinine clearance = 60 ml/min (see appendix C for calculating the
- •creatinine clearance according to the Cockroft-Gault formula)
- •? Adequate hepatic function:
- •? bilirubin = 1.5 x ULN
- •? alkaline phosphatase = 3.0 x ULN
- •? AST/ALT = 3.0 x ULN
- •? The patient should be physically and mentally fit enough to receive chemotherapy in either adjuvant or neo-adjuvant setting and to undergo the proposed resection. A multidisciplinary team will confirm the required fitness.
- •? 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 five years.
- •? No congestive heart failure or angina pectoris except if it is medically controlled. No previoushistory of myocardial infarction within 6 months prior to study entry, nor uncontrolled hypertension or arrhythmia.
- •? No active (uncontrolled) infection requiring antibiotics.
- •? No pre-existing motor or sensory neurotoxicity = grade 2 (Common Terminology Criteria forAdverse Events, Version 3.0)
- •? Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment
- •? Before patient randomization, written informed consent will be obtained and documented according to ICH/GCP, and national/local 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
- 未提供
研究者
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