Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003566
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Pre-Resection Minimally Invasive Surgical Restaging of Stage III Mediastinal Node Positive Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Diagnostic procedures such as thoracoscopy may help to measure a patients response to previous treatment
PURPOSE Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer
PURPOSE Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer
Detailed Description:
OUTLINE The purpose of this study is to test the usefulness and safety of restaging the patients cancer by a procedure called a thoracoscopy Restaging is a process by which physicians measure the response of the patient to treatment The primary and secondary objectives are described below
OBJECTIVES
Primary Objective
1 Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes andor evaluate for other conditions which render patients unresectable pleural carcinomatosis or T4 primary tumors following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer
Secondary Objectives
1 Evaluate the safety morbidity and mortality of pre-resectional thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III N2 NSCLC
2 Assess the accuracy false-negative rate of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy
OBJECTIVES
Primary Objective
1 Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes andor evaluate for other conditions which render patients unresectable pleural carcinomatosis or T4 primary tumors following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer
Secondary Objectives
1 Evaluate the safety morbidity and mortality of pre-resectional thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III N2 NSCLC
2 Assess the accuracy false-negative rate of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066632 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-39803 | None | None | None |