Phase III Comparison of Postoperative 3D Conform Radiotherapy After Chemotherapy and Chemotherapy Alone in Patients With Completely Resected Stage IIIA(N2) Non-small Cell Lung Cancer
Primary: To determine whether administering chemotherapy (four cycles of NP regimen) plus 3D
conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year
survival compared with chemotherapy (four cycles of NP regimen) alone in patients with
completely resected stage IIIA (N2) non-small cell lung cancer.
Secondary: To compare treatment-related toxic effects, failure-free survival, and the
patterns of failure.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
histology (squamous cell vs other), number of mediastinum lymph nodes, and whether N2
disease has been diagnosed before operation.
Arm I: Patients undergo 3D conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5
weeks) after postoperative chemotherapy of four cycles of NP regimen.
Arm II: Patients undergo postoperative chemotherapy of four cycles of NP regimen.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival rate
Luhua Wang, MD
Cancer Instititute and Hosiptal of Chinese Academy of Medical Sciences
China: Ethics Committee