Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293085
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2006-02-16
Brief Title:
An Open Randomized Multicentre Phase II Pilot Study
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
An Open Randomized Multicentre Phase II Pilot Study of Docetaxel and Cisplatin in the Adjuvant Treatment of Non-Small Cell Lung Cancer NSCLC Stage I-II
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The objective of this study is to evaluate efficacy safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected NSCLC Stage I-II
Detailed Description:
Open multicentre centrally randomized two-arm parallel-group phase II pilot-study Duration of the Treatment Arm A - will be 4-6 cycles Docetaxel 75mgm2 and Cisplatin 75mgm2 on day 1 every 21 days
Arm B untreated control group - best supportive care A follow-up check-up examination will be performed every 3 months for a total of three years
Arm B untreated control group - best supportive care A follow-up check-up examination will be performed every 3 months for a total of three years
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