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Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Principal Investigator

Michael T. Jaklitsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066632

NCT ID:

NCT00003566

Start Date:

September 1998

Completion Date:

March 2006

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center West Palm Beach, Florida  33401
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Weill Medical College of Cornell University New York, New York  10021
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Ministry Medical Group - Northern Region Rhinelander, Wisconsin  54501
Brigham and Women's Hospital Boston, Massachusetts  02115