Adjuvant CCRT vs CT in Minimal N2 NSCLC

Phase 2 Completed 17 enrolled Samsung Medical Center

RandomizedParallel-groupOpen-labelTreatment

Summary

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Timeline

Start: 2017-10-23
Primary completion: 2021-01-18
Completion: 2021-01-18

Outcome

Missed primary endpoint

paper The median disease-free survival of the CCRT arm was 24.7 months, which was not significantly different from that of the chemotherapy arm PMID 28962948 ↗

Publications

Sun JM, Noh JM, Oh D, Kim HK, Lee SH, Choi YS, Pyo H, Ahn JS, Jung SH, Ahn YC, Kim J, Ahn MJ, Zo JI, Shim YM, Park K. Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Dec;12(12):1806-1813. doi: 10.1016/j.jtho.2017.09.1954. Epub 2017 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5.5 unknown	—
Subject	Paclitaxel	Small molecule	175 mg/m2	—