Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191126
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2005-09-12
Brief Title:
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early StagesT2N0 T1 - 2N1 T3N0 AND T3N1 Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer NSCLC The use of preoperative CisplatinGemcitabine 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 CisplatinGemcitabine improves progression free survival of NSCLC patients versus surgery alone Postoperative chemotherapy will not be utilized in this Phase III trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B9E-MC-S132 | OTHER | Eli Lilly and Company | None |