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 |
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.
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.
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
We found this trial at
45
sites
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
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Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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Winston-Salem, North Carolina 27157
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