SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002860
Collaborator
National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other)
77
124
1
169
0.6
0
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
77 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up
Study Start Date
:
Nov 1, 1996
Actual Primary Completion Date
:
Dec 1, 2006
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: surgery
|
Procedure: Surgery
Complete surgical resection of metastatic melanoma
|
Outcome Measures
Primary Outcome Measures
- Overall survival [1-year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Regional Hospital Cancer Center | Anchorage | Alaska | United States | 99508 |
| 2 | Banner Good Samaritan Medical Center | Phoenix | Arizona | United States | 85006 |
| 3 | CCOP - Western Regional, Arizona | Phoenix | Arizona | United States | 85006 |
| 4 | Banner Thunderbird Medical Center | Phoenix | Arizona | United States | 85306 |
| 5 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 6 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 7 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
| 8 | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | United States | 32207 |
| 9 | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | United States | 62002 |
| 10 | Good Samaritan Regional Health Center | Mt. Vernon | Illinois | United States | 62864 |
| 11 | Siouxland Regional Cancer Center | Sioux City | Iowa | United States | 51101-1733 |
| 12 | Siouxland Hematology-Oncology Associates | Sioux City | Iowa | United States | 51101 |
| 13 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
| 14 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
| 15 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
| 16 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
| 17 | Cancer Center of Kansas, P.A. - El Dorado | El Dorado | Kansas | United States | 67042 |
| 18 | Veterans Affairs Medical Center - Kansas City | Kansas City | Kansas | United States | 64128 |
| 19 | Cancer Center of Kansas - Kingman | Kingman | Kansas | United States | 67068 |
| 20 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
| 21 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
| 22 | Cancer Center of Kansas, P.A. - Parsons | Parsons | Kansas | United States | 67357 |
| 23 | Pratt Cancer Center of Kansas | Pratt | Kansas | United States | 67124 |
| 24 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67042 |
| 25 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
| 26 | Associates in Womens Health | Wichita | Kansas | United States | 67203 |
| 27 | Cancer Center of Kansas, P.A. | Wichita | Kansas | United States | 67208 |
| 28 | Cancer Center of Kansas, P.A. - Wichita | Wichita | Kansas | United States | 67214 |
| 29 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
| 30 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 31 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 32 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
| 33 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 34 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 35 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
| 36 | Mecosta County General Hospital | Big Rapids | Michigan | United States | 49307 |
| 37 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48202 |
| 38 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
| 39 | Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids | Michigan | United States | 49503 |
| 40 | Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 41 | Metropolitan Hospital | Grand Rapids | Michigan | United States | 49506 |
| 42 | Holland Community Hospital | Holland | Michigan | United States | 49423 |
| 43 | Borgess Medical Center | Kalamazooaa | Michigan | United States | 49001 |
| 44 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 45 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 46 | Hackley Hospital | Muskegon | Michigan | United States | 49443 |
| 47 | Northern Michigan Hospital | Petoskey | Michigan | United States | 49770 |
| 48 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
| 49 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 50 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 51 | St. Francis Medical Center | Cape Girardeau | Missouri | United States | 63701 |
| 52 | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri | United States | 63701 |
| 53 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 54 | CCOP - St. Louis-Cape Girardeau | St. Louis | Missouri | United States | 63141 |
| 55 | David C. Pratt Cancer Center at St. John's Mercy | St. Louis | Missouri | United States | 63141 |
| 56 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 57 | Deaconess Billings Clinic - Downtown | Billings | Montana | United States | 59101 |
| 58 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59101 |
| 59 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
| 60 | St. Vincent Healthcare | Billings | Montana | United States | 59101 |
| 61 | Deaconess Billings Clinic Cancer Center | Billings | Montana | United States | 59107 |
| 62 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 63 | Internal Medicine Associates of Bozeman | Bozeman | Montana | United States | 59715 |
| 64 | St. James Community Hospital | Butte | Montana | United States | 59701 |
| 65 | Big Sky Oncology | Great Falls | Montana | United States | 59405 |
| 66 | Great Falls Clinic | Great Falls | Montana | United States | 59405 |
| 67 | Sletten Regional Cancer Institute | Great Falls | Montana | United States | 59405 |
| 68 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
| 69 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
| 70 | Kalispell Medical Oncology | Kalispell | Montana | United States | 59901 |
| 71 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 72 | Eastern Montana Cancer Center | Miles City | Montana | United States | 59301 |
| 73 | Community Medical Center | Missoula | Montana | United States | 59801 |
| 74 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59802 |
| 75 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59802 |
| 76 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 77 | Fox Chase Virtua Health Cancer Program - Marlton | Marlton | New Jersey | United States | 08053 |
| 78 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 79 | Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio | United States | 44710 |
| 80 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 54601 |
| 81 | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | United States | 45267 |
| 82 | MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 83 | Riverside Methodist Hospital Cancer Care | Columbus | Ohio | United States | 43214 |
| 84 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
| 85 | Grant Riverside Cancer Services | Columbus | Ohio | United States | 43215 |
| 86 | Mount Carmel West Hospital | Columbus | Ohio | United States | 43222 |
| 87 | Doctors Hospital at Ohio Health | Columbus | Ohio | United States | 43228 |
| 88 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
| 89 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
| 90 | St. Rita's Medical Center | Lima | Ohio | United States | 45801 |
| 91 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 92 | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 93 | Mercy Medical Center Oncology Unit | Springfield | Ohio | United States | 45504 |
| 94 | Community Hospital of Springfield and Clark County | Springfield | Ohio | United States | 45505 |
| 95 | Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 96 | Genesis - Good Samaritan Hospital | Zanesville | Ohio | United States | 43701 |
| 97 | Cancer Institute at Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 98 | St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | United States | 18015 |
| 99 | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | United States | 57104 |
| 100 | Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | United States | 57105 |
| 101 | Medical X-Ray Center | Sioux Falls | South Dakota | United States | 57105 |
| 102 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 103 | American Fork Hospital | American Fork | Utah | United States | 84003 |
| 104 | Logan Regional Hospital | Logan | Utah | United States | 84321 |
| 105 | Cottonwood Hospital Medical Center | Murray | Utah | United States | 84107 |
| 106 | McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 107 | Utah Valley Regional Medical Center - Provo | Provo | Utah | United States | 84603 |
| 108 | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | United States | 84106 |
| 109 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 110 | Dixie Regional Medical Center | St. George | Utah | United States | 84770 |
| 111 | St. Joseph Hospital Community Cancer Center | Bellingham | Washington | United States | 98225 |
| 112 | Olympic Hematology and Oncology | Bremerton | Washington | United States | 98310 |
| 113 | Skagit Valley Hospital Cancer Care Center | Mt. Vernon | Washington | United States | 98273 |
| 114 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98104 |
| 115 | Group Health Central Hospital | Seattle | Washington | United States | 98104 |
| 116 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 117 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98114 |
| 118 | University Cancer Center at University of Washington Medical Center | Seattle | Washington | United States | 98195 |
| 119 | North Puget Oncology at United General Hospital | Sedro-Wooley | Washington | United States | 98284 |
| 120 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
| 121 | Central Washington Hospital | Wenatchee | Washington | United States | 98801 |
| 122 | Wenatchee Valley Clinic | Wenatchee | Washington | United States | 98801 |
| 123 | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 124 | Welch Cancer Center | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
- Eastern Cooperative Oncology Group
Investigators
- Study Chair: Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center
- Study Chair: John M. Kirkwood, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002860
Other Study ID Numbers:
- CDR0000065130
- U10CA032102
- SWOG-9430
- ECOG-S9430
First Posted:
Jan 27, 2003
Last Update Posted:
Jan 13, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: