Clinical Trial: Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Contro
Brief Summary: The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.
Detailed Summary:
The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.
In addition, the overall survival and safety index will be collected for analyses.
Sponsor: Shanghai Chest Hospital
Current Primary Outcome: Progression-free survival (PFS) [ Time Frame: 16 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- overall survival (OS) [ Time Frame: 32 months ]
- Objective response rate (ORR) [ Time Frame: 6 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Shanghai Chest Hospital
Dates:
Date Received: October 15, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: October 29, 2016
Last Verified: October 2016
