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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Therapeutic conventional surgery, R0 resection
Thoracic Surgery Department of Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGDisease-Free-Survival-Rate
the percentage of people in the trial who are alive and cancer free after a specified number of years
Time frame: up to 60 months
Overall-Survival-Rate
the percentage of people in the trial who alive, with or without signs of cancer
Time frame: up to 60 months
Disease-Free-Survival-Time
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Time frame: up to 60 months
Overall-Survival-Time
Time from randomization until death from any cause
Time frame: up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.