Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01282151
Status:
TERMINATED
Last Update Posted:
2015-07-14
First Post:
2011-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Sponsor:
Chonnam National University Hospital
Organization:
Study Overview
Official Title:
A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in recruitment due to approval of maintenance pemetrexed treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAIL
Brief Summary:
This study is:
* A multicenter, prospective, randomized, phase 3 trial.
* To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
* 276 patients will be recruited.
* A multicenter, prospective, randomized, phase 3 trial.
* To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
* 276 patients will be recruited.
Detailed Description:
Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.
Study Oversight
Has Oversight DMC:
True
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?: