EUCTR2004-001332-23-BE进行中（未招募）不适用
Phase II Study with Gefitinib (sequentially) following Gemcitabine/Cisplatin as induction regimen for patients with stage IIIA N2 NSCLC.
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 55 人开始时间: 2005年7月19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
- 入组人数
- 55
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
- •? Patients with pathologically proven primary NSCLC.
- •? Patients with clinical stage IIIa (N2) disease (Appendix G) documented on chest CT scan within 4 weeks prior to registration. Histological proof of N2-disease must be obtained by mediastinoscopy /-tomy, thoracotomy or VATS.
- •? Presence of at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional technique or as = 10 mm with spiral CT scan [conform to the RECIST criteria described on response evaluation (section 7.1)].
- •? Age > 18 years.
- •? WHO performance status = 2 (see Appendix B).
- •? The patient should be judged by the responsible thoracic surgeon to have irresectable N2-disease according to the local guidelines.
- •? The patient should be physically and mentally fit enough to receive Gemcitabine-Cisplatincontaining chemotherapy, and to undergo a lobectomy or pneumonectomy after induction therapy. A team consisting of the responsible pulmonologist, medical oncologist, thoracic surgeon, and radiotherapist should confirm the required fitness.
- •? No evidence of N3 or metastatic disease as assessed by physical examination, CT-scan of the thorax, bone scan and investigation of liver and adrenals by CT-scan or ultrasound.
- •? No superior vena cava syndrome.
- •? No pre-existing pleural or pericardial effusion.
- •? No pre-existing diffuse interstitial pulmonary fibrosis.
- •? No symptoms or signs of CNS involvement (CT-brain or MRI before entry is not mandatory in absence of neurological signs or symptoms).
- •? No pre-existing motor or sensory neurotoxicity = grade 2 (Common Toxicity Criteria).
- •? No active (uncontrolled) infection requiring i.v. antibiotics.
- •? No history of hypersensitivity to gefitinib or any excipient of gefitinib.
- •? No concomitant use of phenytoin, carbamazepine, rifampicine, barbiturates or St John's Wort.
- •? No prior therapy for NSCLC (chemotherapy, radiotherapy or surgery).
- •? No secondary primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and renal cell cancer).
- •? Use of any investigational agent in the month before enrolment in the study means ineligibility.
- •? No congestive heart failure or angina pectoris except if it is medically controlled. No previous history of myocardial infarction within 1 year prior to study entry nor uncontrolled hypertension or arrhythmia.
- •? Patients of reproductive potential must agree to practice an effective contraceptive method.
- •Women of childbearing potential must not be pregnant or lactating.
- •? Before patient registration, written informed consent to participate in the study and written informed consent to participate in the translational research part of this study,must 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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