Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

Arms (1)

1. type

   EXPERIMENTAL

   label

   Gemcitabine + Cisplatin

   description

   Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.

   interventionNames

   1. Drug: gemcitabine
   2. Drug: cisplatin
   3. Radiation: radiation

Primary outcomes (1)

1. measure

   Tumor Response at End of Treatment

   timeFrame

   baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)

   description

   Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.