Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00198367
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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) and/or 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: