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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002860 |
Purpose
RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 1996 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable
No metastatic disease beyond the lesions planned for resection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alaska | |
| Alaska Regional Hospital Cancer Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Thunderbird Medical Center | |
| Phoenix, Arizona, United States, 85306 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Colorado | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Illinois | |
| Good Samaritan Regional Health Center | |
| Mt. Vernon, Illinois, United States, 62864 | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| United States, Iowa | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Regional Cancer Center | |
| Sioux City, Iowa, United States, 51101-1733 | |
| Siouxland Hematology-Oncology Associates | |
| Sioux City, Iowa, United States, 51101 | |
| United States, Kansas | |
| Associates in Womens Health | |
| Wichita, Kansas, United States, 67203 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, P.A. - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, P.A. | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Pratt Cancer Center of Kansas | |
| Pratt, Kansas, United States, 67124 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Kansas, United States, 64128 | |
| Cancer Center of Kansas - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48202 | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| St. Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| St. Louis, Missouri, United States, 63141 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Gape Girardeau, Missouri, United States, 63701 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Montana | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Internal Medicine Associates of Bozeman | |
| Bozeman, Montana, United States, 59715 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59802 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| Fox Chase Virtua Health Cancer Program - Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| United States, Ohio | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 54601 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Mercy Medical Center Oncology Unit | |
| Springfield, Ohio, United States, 45504 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214 | |
| St. Rita's Medical Center | |
| Lima, Ohio, United States, 45801 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| St. Luke's Hospital Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, South Dakota | |
| Avera McKennan Hospital and University Health Center | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center | |
| St. George, Utah, United States, 84770 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84603 | |
| United States, Washington | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| United States, Wisconsin | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Jeffrey A. Sosman, MD | Vanderbilt-Ingram Cancer Center |
| Study Chair: | John M. Kirkwood, MD | UPMC Cancer Centers |
More Information
| Study ID Numbers: | CDR0000065130, SWOG-9430, ECOG-S9430 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002860 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |