Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/13/2016
Start Date:February 1999
End Date:February 2007

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Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases

RATIONALE: Video-assisted surgery may have fewer side effects than conventional surgery in
patients with lung metastases. It is not yet known whether conventional surgery or
video-assisted surgery is more effective in treating lung metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery
with that of video-assisted surgery in treating patients who have lung metastases.

OBJECTIVES: I. Compare the overall survival and failure free survival of patients with
isolated pulmonary metastases treated with minimally invasive (video assisted) resection or
open resection. II. Compare patterns of recurrence in these patients after these treatments,
and determine what factors are predictive of recurrence. III. Describe and compare the
complications and morbidity associated with minimally-invasive and open approaches to
metastasectomy in these patients. IV. Test whether the patients undergoing video-assisted
thoracic surgery will have a significantly better quality of life over a six month period
than those undergoing an open resection.

OUTLINE: This is a randomized study. Patients are stratified according to histology (sarcoma
vs epithelial vs germ cell vs melanoma) and disease laterality. After spiral CT showing
pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with
curative intent, patients are randomized to undergo either open resection (thoracotomy,
median sternotomy, or bilateral sternothoracotomy) (arm I) or minimally-invasive
video-assisted resection (arm II). Patients with isolated recurrence in the chest should
have the recurrence(s) resected if feasible. The original resection approach (open versus
VATS) should be the preferred method for the second resection, but is not required. Quality
of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 530 patients accrued into this study in approximately 3
years.

DISEASE CHARACTERISTICS: Histologically confirmed pulmonary metastases (unilateral or
bilateral) identified by spiral CT scan No primary lung cancer Documented previous cancer
with no history of prior metastasectomy Primary tumor must be definitively controlled No
evidence of primary tumor recurrence, either locally or systemically No extrapulmonary
metastatic disease or evidence of mediastinal lymph node involvement Lymph nodes greater
than 1.0 cm on CT scan must be proven to be benign by tissue biopsy (mediastinoscopy) All
lesions must be amenable to minimally invasive resection Must be amenable to
video-assisted thoracic surgery with curative intent (complete removal of all documented
lesions) No greater than 4 lesions

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Pulmonary: See Disease Characteristics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease
Characteristics
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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300 Community Drive
Manhasset, New York 11030
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1331 Union Ave # 800
Memphis, Tennessee 38103
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Columbia, Missouri 65211
(573) 882-2121
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Columbia, Missouri 65203
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Durham, North Carolina 27705
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Lebanon, New Hampshire 03756
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Minneapolis, Minnesota 55417
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1275 York Ave
New York, New York 10021
(212) 639-2000
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New York, New York 10029
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Richmond, Virginia 23298
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Saint Louis, Missouri 63110
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San Francisco, California 94121
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San Francisco, California 94143
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
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Washington, District of Columbia 02007
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White River Junction, Vermont 05009
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Wilmington, Delaware 19899
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Winston-Salem, North Carolina 27104
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