NCT00191126CompletedPhase 3
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 263
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Other
Intervention: surgery (Procedure)
B
Experimental
Intervention: gemcitabine (Drug)
B
Experimental
Intervention: Cisplatin (Drug)
B
Experimental
Intervention: surgery (Procedure)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: baseline to measure progressive disease
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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