Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: videothoracoscopy |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Diagnostic |
| Official Title: | Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC) |
| Enrollment: | 75 |
| Study Start Date: | September 1998 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions that render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy in patients with stage IIIA non-small cell lung cancer.
- Evaluate the safety (morbidity and mortality) of preresectional thoracoscopic restaging of these patients.
- Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging in these patients.
OUTLINE: Patients undergo ipsilateral videothoracoscopic evaluation for restaging their disease after prior mediastinoscopy and induction therapy.
Patients with negative restaging procedures are strongly encouraged to undergo anatomic resection (lobectomy, bilobectomy, or pneumonectomy) with complete mediastinal lymphadenectomy.
Patients with a positive restaging procedure may still undergo resection at the discretion of the surgeon and other treating physicians.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 30 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IIIA non-small lung cancer from a documented mediastinoscopy prior to induction therapy
- Must have been previously treated with at least 2 courses of chemotherapy and/or radiotherapy (at least 40 Gy) within 60 days of registration
- No evidence of distant metastases or local disease progression
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- No prior intrapleural surgery on the ipsilateral side
Contacts and Locations
Show 72 Study Locations| Study Chair: | Michael T. Jaklitsch, MD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003566 History of Changes |
| Other Study ID Numbers: | CDR0000066632, U10CA031946, CLB-39803 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
stage IIIA non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013