Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT00449657
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2007-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC
Sponsor:
Leo W. Jenkins Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual, change in standard of care.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES Primary
1. Overall survival
2. Tumor response using RECIST criteria
Secondary
1. Determine the toxicity of the proposed treatment in this patient population.
2. Progression free survival
3. Locoregional control
4. Distant failure
STUDY DESIGN
Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer.
Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination.
Outcome Measures Primary Outcome Measures
1. Overall survival
2. Tumor response using RECIST criteria
Secondary Outcome Measures
1. Locoregional control
2. Distant Failure
3. Progression free survival
1. Overall survival
2. Tumor response using RECIST criteria
Secondary
1. Determine the toxicity of the proposed treatment in this patient population.
2. Progression free survival
3. Locoregional control
4. Distant failure
STUDY DESIGN
Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer.
Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination.
Outcome Measures Primary Outcome Measures
1. Overall survival
2. Tumor response using RECIST criteria
Secondary Outcome Measures
1. Locoregional control
2. Distant Failure
3. Progression free survival
Study Oversight
Has Oversight DMC:
False
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?: