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A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up


- Assess overall and progression-free survival in patients with metastatic melanoma
(beyond the draining lymph nodes) after complete surgical resection of all known

- 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.

Inclusion Criteria


- Histologically confirmed metastatic melanoma that is deemed grossly surgically

- 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



- 18 and over

Performance status:

- SWOG 0-2


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy:

- Prior immunotherapy in the adjuvant or metastatic setting allowed


- Prior chemotherapy in the adjuvant or metastatic setting allowed

Endocrine therapy:

- Prior hormonal therapy in the adjuvant or metastatic setting allowed


- Prior radiotherapy in the adjuvant or metastatic setting allowed


- See Disease Characteristics

- At least 14 days since prior surgery in the adjuvant or metastatic setting


- Recovered from prior therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jeffrey A. Sosman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1996

Completion Date:

December 2010

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



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Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
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Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
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Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
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Northern Rockies Radiation Oncology Center Billings, Montana  59101
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Deaconess Billings Clinic - Downtown Billings, Montana  59101
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Internal Medicine Associates of Bozeman Bozeman, Montana  59715
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St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
Sletten Regional Cancer Institute Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
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Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
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Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mercy Medical Center Oncology Unit Springfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Medical X-Ray Center Sioux Falls, South Dakota  57105
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Olympic Hematology and Oncology Bremerton, Washington  98310
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University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
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Central Washington Hospital Wenatchee, Washington  98801
Wenatchee Valley Clinic Wenatchee, Washington  98801
Welch Cancer Center Sheridan, Wyoming  82801