Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT01038661
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2009-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel （60mg/m2）Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel（75/60mg/m2）in Combination With Cisplatin in Patients With Local Advanced or Metastatic （Stage IIIB/IV）Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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:
TFINE
Brief Summary:
The Primary Objective is to evaluate the progression-free survival (PFS).
The secondary objectives are:
* To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;
* To evaluate the overall response rate (ORR);
* To evaluate the time to disease progression (TTP);
* To evaluate the overall survival (OS);
* To evaluate the toxicity.
The secondary objectives are:
* To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;
* To evaluate the overall response rate (ORR);
* To evaluate the time to disease progression (TTP);
* To evaluate the overall survival (OS);
* To evaluate the toxicity.
Detailed Description:
The study consists in:
* A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,
* A maintenance treatment phase: participants with disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).
* A follow-up period from the end of study treatment until participant death or end of study.
* A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,
* A maintenance treatment phase: participants with disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).
* A follow-up period from the end of study treatment until participant death or end of study.
Study Oversight
Has Oversight DMC:
False
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?: