Treatment Clinical Trial
Official title:
A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis,
and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a
more appropriate treatment for these patients, we perform this randomized phase II clinical
trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20%
will be included and divided into two group. Patients in the control group will only undergo
complete R0 resection of the lesion, no further therapy will be used. While patients in the
experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and
pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3
weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data
monitoring.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using
the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will
be performed using the log-rank test.
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