NCT03351842

Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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%.

Detailed description

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.

Conditions

• Chemotherapy, Adjuvant
• Lung Adenocarcinoma, Stage I
• Treatment
• Histological Type of Neoplasm

Interventions

Type	Name	Description
DRUG	cis Platinum/Carboplatin, Pemetrexed Disodium	Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
PROCEDURE	Undergo surgery	Therapeutic conventional surgery, R0 resection

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-09-01
• Completion: 2024-09-01
• First posted: 2017-11-24
• Last updated: 2017-12-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study