Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer

The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.

Inclusion Criteria:

• cytological or histologically proven NSCLC
• unresectable stage III NSCLC
• presence of at least one measurable lesion (RECIST criteria)
• adequate haematological, renal and hepatic function
• adequate lung function reserve
• good condition, weight loss <10% over previous 6 months, life expectancy > 3 months

Exclusion Criteria:

• previous chemotherapy for NSCLC
• distant metastasis or a pleural or pericardial effusion
• treatment for malignant disease in the past or serious concomitant medical or psychiatric disease
• active uncontrolled infection at time of inclusion
• interstitial lung disease
• auto-immune systemic disease with potential involvement of the lungs
• concomitant use of amiodarone