Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00003692
Collaborator
National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other)
128
115
1
87
1.1
0
Study Details
Study Description
Brief Summary
RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.
OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study
Study Start Date
:
Dec 1, 1998
Actual Primary Completion Date
:
Mar 1, 2006
Actual Study Completion Date
:
Mar 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: video-assisted surgery Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years. |
Procedure: therapeutic thoracoscopy
Procedure: video-assisted surgery
|
Outcome Measures
Primary Outcome Measures
- survival [up to 5 years]
- failure-free survival [up to 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS: Suspected or histologically documented non-small cell lung cancer Solitary, peripheral lung lesion that is no greater than 3.0 cm No metastatic disease No positive lymph nodes at mediastinoscopy At least 5 years since diagnosis of non-small cell or small cell lung cancer
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: FEV1 at least 1.0 L or at least 50% of predicted Other: No significant comorbid medical or psychiatric condition No other active malignancy other than nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | United States | 85259-5404 |
| 3 | University of California San Diego Cancer Center | La Jolla | California | United States | 92093-0658 |
| 4 | Beckman Research Institute, City of Hope | Los Angeles | California | United States | 91010 |
| 5 | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | United States | 94304 |
| 6 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94115-0128 |
| 7 | Veterans Affairs Medical Center - San Francisco | San Francisco | California | United States | 94121 |
| 8 | Stanford University Medical Center | Stanford | California | United States | 94305-5408 |
| 9 | CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | United States | 80209-5031 |
| 10 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
| 11 | Lombardi Cancer Center, Georgetown University | Washington | District of Columbia | United States | 20007 |
| 12 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 13 | Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | United States | 32608-1197 |
| 14 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 15 | Veterans Affairs Medical Center - Miami | Miami | Florida | United States | 33125 |
| 16 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 17 | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | United States | 33612 |
| 18 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 19 | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | United States | 30033 |
| 20 | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | United States | 60611 |
| 21 | Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | United States | 60611 |
| 22 | University of Illinois at Chicago Health Sciences Center | Chicago | Illinois | United States | 60612 |
| 23 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
| 24 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637 |
| 25 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 26 | CCOP - Evanston | Evanston | Illinois | United States | 60201 |
| 27 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61602 |
| 28 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 29 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5265 |
| 30 | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | United States | 46202 |
| 31 | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | United States | 52403-1206 |
| 32 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
| 33 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 34 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
| 35 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 36 | CCOP - Ochsner | New Orleans | Louisiana | United States | 70121 |
| 37 | Veterans Affairs Medical Center - Togus | Togus | Maine | United States | 04330 |
| 38 | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | United States | 21201 |
| 39 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231 |
| 40 | New England Medical Center Hospital | Boston | Massachusetts | United States | 02111 |
| 41 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 42 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 43 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 44 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 45 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 46 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-3731 |
| 47 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 48 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 49 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 50 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 51 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 52 | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | United States | 65201 |
| 53 | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | United States | 65203 |
| 54 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 55 | Veterans Affairs Medical Center - Omaha | Omaha | Nebraska | United States | 68105 |
| 56 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68131 |
| 57 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-3330 |
| 58 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 59 | Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756 |
| 60 | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | United States | 07018-1095 |
| 61 | CCOP - Northern New Jersey | Hackensack | New Jersey | United States | 07601 |
| 62 | Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
| 63 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
| 64 | Albert Einstein Comprehensive Cancer Center | Bronx | New York | United States | 10461 |
| 65 | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | United States | 11209 |
| 66 | Veterans Affairs Medical Center - Buffalo | Buffalo | New York | United States | 14215 |
| 67 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 68 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 69 | Veterans Affairs Medical Center - New York | New York | New York | United States | 10010 |
| 70 | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | United States | 10016 |
| 71 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 72 | New York Presbyterian Hospital - Cornell Campus | New York | New York | United States | 10021 |
| 73 | Mount Sinai Medical Center, NY | New York | New York | United States | 10029 |
| 74 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 75 | State University of New York - Upstate Medical University | Syracuse | New York | United States | 13210 |
| 76 | Veterans Affairs Medical Center - Syracuse | Syracuse | New York | United States | 13210 |
| 77 | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | United States | 13217 |
| 78 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 79 | Veterans Affairs Medical Center - Durham | Durham | North Carolina | United States | 27705 |
| 80 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 81 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
| 82 | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157-1082 |
| 83 | CCOP - Merit Care Hospital | Fargo | North Dakota | United States | 58122 |
| 84 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 85 | Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | United States | 44106 |
| 86 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 87 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 88 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210 |
| 89 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
| 90 | CCOP - Sooner State | Tulsa | Oklahoma | United States | 74136 |
| 91 | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
| 92 | Hahnemann University Hospital | Philadelphia | Pennsylvania | United States | 19102-1192 |
| 93 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 94 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 95 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15213 |
| 96 | Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | United States | 15240 |
| 97 | CCOP - MainLine Health | Wynnewood | Pennsylvania | United States | 19096 |
| 98 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 99 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 100 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57105-1080 |
| 101 | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | United States | 38103 |
| 102 | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | United States | 38104 |
| 103 | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | United States | 37212 |
| 104 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 105 | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | United States | 05009 |
| 106 | Veterans Affairs Medical Center - Richmond | Richmond | Virginia | United States | 23249 |
| 107 | MBCCOP - Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 108 | Veterans Affairs Medical Center - Madison | Madison | Wisconsin | United States | 53705 |
| 109 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792 |
| 110 | CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | United States | 54449 |
| 111 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 112 | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | United States | 53295 |
| 113 | MBCCOP - San Juan | San Juan | Puerto Rico | 00927-5800 | |
| 114 | Veterans Affairs Medical Center - San Juan | San Juan | Puerto Rico | 00927-5800 | |
| 115 | Pretoria Academic Hospitals | Pretoria | South Africa | 0001 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
- Eastern Cooperative Oncology Group
Investigators
- Study Chair: Scott J. Swanson, MD, Dana-Farber/Brigham and Women's Cancer Center
- Study Chair: John R. Roberts, MD, MBA, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003692
Other Study ID Numbers:
- CALGB-39802
- U10CA031946
- CLB-39802
- E-C39802
- CDR0000066795
First Posted:
Apr 9, 2004
Last Update Posted:
Jul 20, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms: