Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Procedure: surgical procedure |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases |
| Study Start Date: | February 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, California | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Lombardi Cancer Center, Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| University of Illinois at Chicago Health Sciences Center | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| Veterans Affairs Medical Center - Togus | |
| Togus, Maine, United States, 04330 | |
| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38103 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Vermont | |
| Veterans Affairs Medical Center - White River Junction | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Veterans Affairs Medical Center - Richmond | |
| Richmond, Virginia, United States, 23249 | |
| Study Chair: | Joshua R. Sonett, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003724 History of Changes |
| Other Study ID Numbers: | CDR0000066833, CLB-39804 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
lung metastases |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013