A randomised pilot study to investigate the optimum timing of gemcitabine and concurrent radiation therapy after induction gemcitabine and carboplatin for locally advanced non-small cell lung cancer

INTERVENTION: A randomised trial consisting of arms A and B. Both arms commence induction chemotherapy Day 1 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 8 Gemcitabine 1000mg/m2 Day 22 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 29 Gemcitabine 1000mg/m2 with Concurrent treatment, radiation and Gemcitabine treatment. Arm A will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given 5 or more hours prior to the radiation. Arm B will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given within 3 hours or less prior to the radiation. CONDITION: Advanced non‐small cell lung cancer PRIMARY OUTCOME: Objective response rate within the irradiated volume SECONDARY OUTCOME: 1. Toxicity 2. Progression‐free survival 3. Overall survival INCLUSION CRITERIA: Histologically or cytologically proven non‐small cell lung cancer.‐Planned moderate dose radiation therapy for locoregional control. ‐Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have solitary metastasis. If in the brain the metastasis must be operable‐Patients must have measurable disease on imaging scans.