SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma
NCT ID: NCT00002860
Last Updated: 2012-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
1996-11-30
2010-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.
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Detailed Description
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* Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
* Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state.
OUTLINE: This is a multicenter study.
All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431.
Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician.
Patients are followed periodically for 5 years after study entry.
PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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surgery
Surgery
Complete surgical resection of metastatic melanoma
Interventions
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Surgery
Complete surgical resection of metastatic melanoma
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable
* Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected
* Recurrence in iliac lymph nodes after inguinal lymph dissection allowed
* No metastatic disease beyond the lesions planned for resection
* Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study
* Concurrent registration on protocol SWOG-9431 required
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior immunotherapy in the adjuvant or metastatic setting allowed
Chemotherapy:
* Prior chemotherapy in the adjuvant or metastatic setting allowed
Endocrine therapy:
* Prior hormonal therapy in the adjuvant or metastatic setting allowed
Radiotherapy:
* Prior radiotherapy in the adjuvant or metastatic setting allowed
Surgery:
* See Disease Characteristics
* At least 14 days since prior surgery in the adjuvant or metastatic setting
Other:
* Recovered from prior therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Jeffrey A. Sosman, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
John M. Kirkwood, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Banner Thunderbird Medical Center
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
North Colorado Medical Center
Greeley, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates in Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County General Hospital
Big Rapids, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Metropolitan Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazooaa, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Sletten Regional Cancer Institute
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Eastern Montana Cancer Center
Miles City, Montana, United States
Community Medical Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Riverside Cancer Services
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Harrington Cancer Center
Amarillo, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Central Washington Hospital
Wenatchee, Washington, United States
Wenatchee Valley Clinic
Wenatchee, Washington, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Sondak VK, Liu PY, Warneke J, et al.: Surgical resection for stage IV melanoma: a Southwest Oncology Group trial (S9430). [Abstract] J Clin Oncol 24 (Suppl 18): A-8019, 457s, 2006.
Other Identifiers
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SWOG-9430
Identifier Type: -
Identifier Source: secondary_id
ECOG-S9430
Identifier Type: -
Identifier Source: secondary_id
CDR0000065130
Identifier Type: -
Identifier Source: org_study_id
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