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CompletedNCT00002860Updated Jan 13, 2012

SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

A Phase 2 interventional study of Surgery in Melanoma (Skin), sponsored by SWOG Cancer Research Network. Completed at 124 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-13.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage IV melanoma
  • recurrent melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 77 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Other
    surgery

    Procedure: Surgery

Interventions

  • ProcedureSurgery

    Complete surgical resection of metastatic melanoma

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 1-year

07

Study locations

124 sites
  • Alaska Regional Hospital Cancer Center
    Anchorage, Alaska 99508, United States
  • Banner Good Samaritan Medical Center
    Phoenix, Arizona 85006, United States
  • CCOP - Western Regional, Arizona
    Phoenix, Arizona 85006, United States
  • Banner Thunderbird Medical Center
    Phoenix, Arizona 85306, United States
  • Arizona Cancer Center at University of Arizona Health Sciences Center
    Tucson, Arizona 85724, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Baptist Cancer Institute - Jacksonville
    Jacksonville, Florida 32207, United States
  • Saint Anthony's Hospital at Saint Anthony's Health Center
    Alton, Illinois 62002, United States
  • Good Samaritan Regional Health Center
    Mt. Vernon, Illinois 62864, United States
  • Siouxland Regional Cancer Center
    Sioux City, Iowa 51101-1733, United States
  • Siouxland Hematology-Oncology Associates
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center - Sioux City
    Sioux City, Iowa 51104, United States
  • St. Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Cancer Center of Kansas - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, P.A. - El Dorado
    El Dorado, Kansas 67042, United States
  • Veterans Affairs Medical Center - Kansas City
    Kansas City, Kansas 64128, United States
  • Cancer Center of Kansas - Kingman
    Kingman, Kansas 67068, United States
  • Southwest Medical Center
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, P.A. - Parsons
    Parsons, Kansas 67357, United States
  • Pratt Cancer Center of Kansas
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas - Salina
    Salina, Kansas 67042, United States
  • Cancer Center of Kansas - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health
    Wichita, Kansas 67203, United States
  • Cancer Center of Kansas, P.A.
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, P.A. - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Wesley Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas - Winfield
    Winfield, Kansas 67156, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Battle Creek Health System Cancer Care Center
    Battle Creek, Michigan 49017, United States
  • Mecosta County General Hospital
    Big Rapids, Michigan 49307, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48202, United States
  • CCOP - Grand Rapids
    Grand Rapids, Michigan 49503, United States
  • Lacks Cancer Center at Saint Mary's Mercy Medical Center
    Grand Rapids, Michigan 49503, United States
  • Spectrum Health Cancer Care - Butterworth Campus
    Grand Rapids, Michigan 49503, United States
  • Metropolitan Hospital
    Grand Rapids, Michigan 49506, United States
  • Holland Community Hospital
    Holland, Michigan 49423, United States
  • Borgess Medical Center
    Kalamazooaa, Michigan 49001, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007, United States
  • Hackley Hospital
    Muskegon, Michigan 49443, United States
  • Northern Michigan Hospital
    Petoskey, Michigan 49770, United States
  • William Beaumont Hospital - Royal Oak Campus
    Royal Oak, Michigan 48073, United States
  • Munson Medical Center
    Traverse City, Michigan 49684, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • St. Francis Medical Center
    Cape Girardeau, Missouri 63701, United States
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
    Gape Girardeau, Missouri 63701, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • CCOP - St. Louis-Cape Girardeau
    St. Louis, Missouri 63141, United States
  • David C. Pratt Cancer Center at St. John's Mercy
    St. Louis, Missouri 63141, United States
  • CCOP - Montana Cancer Consortium
    Billings, Montana 59101, United States
  • Deaconess Billings Clinic - Downtown
    Billings, Montana 59101, United States
  • Hematology-Oncology Centers of the Northern Rockies - Billings
    Billings, Montana 59101, United States
  • Northern Rockies Radiation Oncology Center
    Billings, Montana 59101, United States
  • St. Vincent Healthcare
    Billings, Montana 59101, United States
  • Deaconess Billings Clinic Cancer Center
    Billings, Montana 59107, United States
  • Bozeman Deaconess Hospital
    Bozeman, Montana 59715, United States
  • Internal Medicine Associates of Bozeman
    Bozeman, Montana 59715, United States
  • St. James Community Hospital
    Butte, Montana 59701, United States
  • Big Sky Oncology
    Great Falls, Montana 59405, United States
  • Great Falls Clinic
    Great Falls, Montana 59405, United States
  • Sletten Regional Cancer Institute
    Great Falls, Montana 59405, United States
  • St. Peter's Hospital
    Helena, Montana 59601, United States
  • Glacier Oncology, PLLC
    Kalispell, Montana 59901, United States
  • Kalispell Medical Oncology
    Kalispell, Montana 59901, United States
  • Kalispell Regional Medical Center
    Kalispell, Montana 59901, United States
  • Eastern Montana Cancer Center
    Miles City, Montana 59301, United States
  • Community Medical Center
    Missoula, Montana 59801, United States
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    Missoula, Montana 59802, United States
  • Montana Cancer Specialists at Montana Cancer Center
    Missoula, Montana 59802, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Fox Chase Virtua Health Cancer Program - Marlton
    Marlton, New Jersey 08053, United States
  • Wayne Memorial Hospital, Incorporated
    Goldsboro, North Carolina 27534, United States
  • Aultman Hospital Cancer Center at Aultman Health Foundation
    Canton, Ohio 44710, United States
  • Adena Regional Medical Center
    Chillicothe, Ohio 54601, United States
  • Charles M. Barrett Cancer Center at University Hospital
    Cincinnati, Ohio 45267, United States
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
  • Riverside Methodist Hospital Cancer Care
    Columbus, Ohio 43214, United States
  • CCOP - Columbus
    Columbus, Ohio 43215, United States
  • Grant Riverside Cancer Services
    Columbus, Ohio 43215, United States
  • Mount Carmel West Hospital
    Columbus, Ohio 43222, United States
  • Doctors Hospital at Ohio Health
    Columbus, Ohio 43228, United States
  • Grady Memorial Hospital
    Delaware, Ohio 43015, United States
  • Fairfield Medical Center
    Lancaster, Ohio 43130, United States
  • St. Rita's Medical Center
    Lima, Ohio 45801, United States
  • Strecker Cancer Center at Marietta Memorial Hospital
    Marietta, Ohio 45750, United States
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
    Newark, Ohio 43055, United States
  • Mercy Medical Center Oncology Unit
    Springfield, Ohio 45504, United States
  • Community Hospital of Springfield and Clark County
    Springfield, Ohio 45505, United States
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
    Westerville, Ohio 43081, United States
  • Genesis - Good Samaritan Hospital
    Zanesville, Ohio 43701, United States
  • Cancer Institute at Oregon Health and Science University
    Portland, Oregon 97239, United States
  • St. Luke's Hospital Cancer Center
    Bethlehem, Pennsylvania 18015, United States
  • Sioux Valley Hospital and University of South Dakota Medical Center
    Sioux Falls, South Dakota 57104, United States
  • Avera McKennan Hospital and University Health Center
    Sioux Falls, South Dakota 57105, United States

Showing the first 100 of 124 sites.

08

References and documents

Publications

  • 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.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002860
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Nov 1996
Primary completion
Dec 2006
Completion
Dec 2010
Last update
Jan 13, 2012

Study contacts

Jeffrey A. Sosman, MD
study chair · Vanderbilt-Ingram Cancer Center
John M. Kirkwood, MD
study chair · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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