Conditions: Non-small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: cisplatin intervention 4: etoposide intervention 5: radiation therapy
Intervention descriptions: intervention 1: After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles. intervention 2: Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine. intervention 3: As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles) intervention 4: As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles) intervention 5: In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks

Protocol document: