EUCTR2006-004713-18-BE进行中（未招募）不适用
A phase II study assessing the curative effect of the combination of lobectomy followed by mediastinal concomitant radiochemotherapy in patients with locally advanced unresectable stage III non-small cell lung cancer responding to induction chemotherapy.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- •- Initially stage III NSCLC
- •- Pathologically proven N2 or N3 disease
- •- Any response to induction chemotherapy (whatever the regimen administered)
- •- Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy
- •- Lobectomy possible for the treatment of T disease
- •- Availability for participating in the detailed follow-up of the protocol
- •- Informed consent
- •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 radiotherapy or surgery
- •- Karnofsky PS < 60
- •- Functional or anatomical contra-indication to mediastinal radiotherapy
- •- Functional or anatomical contra-indication to surgical lobectomy
- •- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
- •- malignant pleural or pericardial effusion
- •- Neutrophils < 2,000/mm³
- •- Platelet cells < 100,000/mm3
- •- Serum bilirubin > 1.5 mg/100 ml
- •- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- •- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- •- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
- •- Uncontrolled infectious disease
- •- Hearing loss
- •- Symptomatic polyneuropathy
- •- Serious medical or psychological factors which may prevent adherence to the treatment schedule
研究者
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