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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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