Phase Ⅰ Study to Determine MTD of Docetaxel and Cisplatin with Concurrent Radiation Therapy for Stag

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Objective: To evaluate the maximum tolerated dose (MTD) of docetaxel (DCT) and cisplatin (DDP) concurrently with three dimensional (3D) conformal radiotherapy or IMRT for patients with locally advanced non-small cell lung cancer (stage Ⅲa and Ⅲb) after 2-4 cycles of induction chemotherapy. Methods: Fourteen patients with histological/cytological proven stage Ⅲ non-small-cell lung cancer were eligible. 3D or IMRT radiotherapy (60-70Gy in 30-35 fractions, 6-7weeks, 2 Gy/fraction) was delivered concurrently with cisplatin and docetaxel, 2 cycles during concurrent chemoradiotherapy (CCRT). The level I dosage was composed of 56 mg/m2 DCT, on day 1 and 28mg/m2 DDP, on day 1 and day 2. The level Ⅱ was composed of 60 mg/m2 DCT, on day 1 and 30 mg/m2 DDP, on day 1 and day 2. The level Ⅲ was composed of 64 mg/m2 DCT, on day 1 and 32 mg/m2 DDP, on day 1 and day 2. Results: Fourteen patients were allocated and finished concurrent chemoradiotherapy. The dose-limiting neutropenia was at the dose Level Ⅲ (64 mg/m2) and occurred in 2 of 5 patients. No dose limiting non-hematologic or hematologic toxicity occurred in the other patients. Conclusions: Patients with locally advanced non-small cell lung cancer may tolerate 60mg/m2 docetaxel and 60mg/m2 cisplatin for 2 cycles during concurrent radiotherapy after 2-3 cycles of induction chemotherapy.
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