Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442026
Status:
TERMINATED
Last Update Posted:
2012-06-27
First Post:
2007-02-28
Brief Title:
Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC
Sponsor:
Hellenic Oncology Research Group
Organization:
Hellenic Oncology Research Group
Study Overview
Official Title:
A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC
Detailed Description:
Docetaxel and gemcitabine are well known active agents in the treatment of NSCLC The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent However there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation
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