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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- 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
- Known hypersensitivity to docetaxel or cisplatin
- Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive
method