Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00191126
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A surgery - B surgery - B gemcitabine - B Cisplatin -
- Primary Outcome Measures
Name Time Method Progression free survival baseline to measure progressive disease
- Secondary Outcome Measures
Name Time Method Response rate baseline to measured progressive disease Pharmacology toxicity every cycle To compare the survival and sites of relapse in the two study arms. baseline to progressive disease Pathologic response rate of tissue samples baseline, post chemotherapy, post surgery
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician.
🇨🇳Taichung, Taiwan