A phase III randomised study comparing concomitant radiochemotherapy with cisplatin and docetaxel as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer

CHRU de Lille0 个研究点目标入组 246 人开始时间: 2009年3月19日最近更新: 2018年3月26日

适应症

试验速览

暂无简介。

•- Men or women aged = 18 years old
•- Histological or cytological diagnosis of non-small cell carcinoma of the lung
•- Initially unresectable non-metastatic stage III disease
•- Availability for participating in the detailed follow-up of the protocol
•- Presence of an evaluable or measurable lesion
•- Written informed consent
•- No functional or anatomical contraindication to chest irradiation
•- Irradiation technically possible
•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

•- Prior treatment with chemotherapy, radiotherapy or surgery
•- Performance status < 60 on the Karnofsky scale
•- 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)
•- Neutrophils < 2,000/mm³
•- Platelet cells < 100,000/mm3
•- Serum bilirubin > 1.5 mg/100 ml
•- Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT = 2.5x the normal value and/or alkaline phosphatase = 5x the normal value
•- 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) or uncontrolled angina pectoris
•- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
•- Uncontrolled infectious disease
•- Symptomatic polyneuropathy
•- Auditive impairment contra-indicating cisplatin administration
•- Serious medical or psychological factors which may prevent adherence to the treatment schedule
•- Malignant pleural or pericardial effusion
•- Homolateral supraclavicular lymph node excepting upper lobe lesion
•- Heterolateral supraclavicular lymph node
•- Allergy or known hypersensitivity to docetaxel or cisplatin
•- Women of child bearing potential not consenting to use adequate contraceptive precautions
•- Female subject who is pregnant or breastfeeding
•- Aberrations from the radiotherapy guidelines

发起方

CHRU de Lille