Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198367
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2005-09-13
Brief Title:
Three Modalities of Treatment in Operable and Resectable Stage IIIA T1-3 N2 Non-Small Cell Lung Cancer NSCLC
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Three Modalities of Treatment in Operable and Resectable Stage IIIA T1-3 N2 NSCLC Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30 of the NSCLCs They are almost always potentially resectable but the results obtained by surgery alone or surgery followed by chemotherapy CT andor radiotherapy RT are insufficient The neoadjuvant approach was tested in randomized tests of exclusive CT or in noncomparative tests of RT-CT
Detailed Description:
These results justify the choice of the study design currently suggested testing the preoperative feasibility
1 chemotherapy cisplatin-Gemzar arm A or
2 chemoradiotherapy cisplatin-navelbine-radiotherapy arm B or Carboplatin-Taxol-radiotherapy arm C
The results obtained in terms of feasibility and toxicity will make it possible to select the optimal diagrams for a phase III study
1 chemotherapy cisplatin-Gemzar arm A or
2 chemoradiotherapy cisplatin-navelbine-radiotherapy arm B or Carboplatin-Taxol-radiotherapy arm C
The results obtained in terms of feasibility and toxicity will make it possible to select the optimal diagrams for a phase III study
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