Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02276560
Status:
TERMINATED
Last Update Posted:
2017-05-11
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to lack of funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LCCC1407
Brief Summary:
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.
Detailed Description:
Objectives
To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.
Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin
Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin
Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance
Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.
Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine
Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.
After the two years of follow-up, subjects will be followed for survival and disease status
Estimate overall survival for entire group and stratified by nodal clearance
To estimate event free survival (EFS)
Estimate time to distant recurrence and time to local recurrence following total study procedures
To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.
Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin
Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin
Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance
Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.
Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine
Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.
After the two years of follow-up, subjects will be followed for survival and disease status
Estimate overall survival for entire group and stratified by nodal clearance
To estimate event free survival (EFS)
Estimate time to distant recurrence and time to local recurrence following total study procedures
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?: