OBJECTIVES:
Primary: To determine whether administering adjuvant chemotherapy (four cycles of platinum-based doublet regimen) plus PORT (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year DFS compared with adjuvant chemotherapy alone in patients with completely resected stage IIIA (N2) NSCLC.
Secondary: To compare treatment-related toxic effects, 3-year OS, failure-free survival, and the patterns of failure.
OUTLINE: Eligible patients were randomized equally, using simple randomization, to either PORT or observation group.
Arm I: Patients undergo PORT using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after adjuvant chemotherapy.
Arm II: Patients undergo adjuvant chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
