Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321334
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2006-05-01
Brief Title:
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
Sponsor:
Chinese Society of Lung Cancer
Organization:
Chinese Society of Lung Cancer
Study Overview
Official Title:
Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-08
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 the trial is to determine whether 3 cycles of TP docetaxel plus cisplatin after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC
Detailed Description:
Non-small-cell lung cancer NSCLC accounts for approximately 80 of lung cancers diagnosed worldwide Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease however the vast majority of patients experience eventually relapse or metastasis The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease so it appears to improve survival by reducing the occurrence of distant metastases Meta analysis CALGB 9633 JBR 10 and ANITA trials have shown postoperative adjuvant CT after complete resection will prolong survival On the other hand Depierre et al had conducted a trial to demonstrate preoperative neoadjuvant chemotherapy in early stage NSCLC appears to improve survival We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC Based on proven activity and survival benefit in advance NSCLC docetaxel has been introduced into neoadjuvant therapy even as a potential option in adjuvant setting
Comparison 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC
Comparison 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC
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