Trials / Completed
CompletedNCT00003566
Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer
Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment. 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 patient's 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 and/or 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | videothoracoscopy |
Timeline
- Start date
- 1998-09-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2003-01-27
- Last updated
- 2016-07-14
Locations
72 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00003566. Inclusion in this directory is not an endorsement.