EUCTR2004-001331-36-GB进行中（未招募）1 期
A randomized phase III study of follow up with or without adjuvant Gefitinib(IressaTM) following chemotherapy in patients with advanced non-small cell lungcancer
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 0 人开始时间: 2008年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •? Histologically and/or cytologically proven NSCLC.
- •? Patients with clinical stage IV or IIIB (with pleural fluid and/or supraclavicular nodes – provided not eligible for consolidation radiotherapy).
- •? Patients with brain metastases are eligible, provided the latter are asymptomatic after cranial irradiation. The latter should be ended for at least 4 weeks.
- •? WHO performance status 0-2 (cf. Appendix B)
- •? Age = 18 years
- •? Absence of progression after a minimum of 2 and a maximum of 6 cycles of platinum containing palliative first line chemotherapy; confirmation of objective response is not mandatory. Last response evaluation should be not older than 3 weeks before randomisation.
- •The criteria of response evaluation (WHO or RECIST) are left at the investigator’s discretion.
- •? Absence of grade 3/4 toxicity caused by prior chemotherapy (except alopecia)
- •? Absence of other malignant disease, unless in remission for at least 5 years. Patients with basal cell carcinoma of the skin or adequately treated superficial carcinoma of the cervix are eligible regardless of this interval.
- •? Patients of reproductive potential must agree to practice an effective contraceptive method.
- •Women of childbearing potential must not be pregnant or lactating.
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
- •? Before patient randomization, written informed consent must be given according to
- •ICH/GCP, and national/local regulations.
- •Patients can only be randomized in this trial once.
- •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
- •? Prior treatment with EGFR inhibitors
- •? History, signs or symptoms of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
- •? Concomitant use of the following drugs: phenytoin, carbamazepine, rifampicin,
- •phenobarbital or St John's Wort
研究者
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