Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

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.

The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

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