A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer
Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage
IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only
microscopically invaded to those that are radiologically visible with bulky ipsilateral
mediastinal lymph node involvement. Surgical resection in selected patients results in
5-year survival rates of 7-24%.
The standard treatment for locally advanced clinical N2 disease is definitive concurrent
chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in
some patients, N2 status could be confirmed only after curative operation without any
evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy).
We usually define those N2 disease found only after curative operation as microscopic N2,
and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little
data about the adjuvant therapy for completely resected N2 disease have been available,
Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs
chemotherapy alone in completely resected microscopic N2 NSCLC.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Keunchil Park, M.D., Ph.D
Samsung Medical Center
Korea: Food and Drug Administration