SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

January 11, 2012 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Regional Hospital Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
      • Phoenix, Arizona, United States, 85006
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, United States, 85306
        • Banner Thunderbird Medical Center
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Colorado
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute - Jacksonville
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Mt. Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
    • Iowa
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kansas City, Kansas, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, United States, 67124
        • Pratt Cancer Center of Kansas
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67203
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, P.A.
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, United States, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, United States, 49307
        • Mecosta County General Hospital
      • Detroit, Michigan, United States, 48202
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, United States, 49503
        • Lacks Cancer Center at Saint Mary's Mercy Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Cancer Care - Butterworth Campus
      • Grand Rapids, Michigan, United States, 49506
        • Metropolitan Hospital
      • Holland, Michigan, United States, 49423
        • Holland Community Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazooaa, Michigan, United States, 49001
        • Borgess Medical Center
      • Muskegon, Michigan, United States, 49443
        • Hackley Hospital
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, United States, 63701
        • St. Francis Medical Center
      • Gape Girardeau, Missouri, United States, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • St. Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • St. Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic - Downtown
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
      • Billings, Montana, United States, 59107
        • Deaconess Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, United States, 59715
        • Internal Medicine Associates of Bozeman
      • Butte, Montana, United States, 59701
        • St. James Community Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Regional Cancer Institute
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Miles City, Montana, United States, 59301
        • Eastern Montana Cancer Center
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59802
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists at Montana Cancer Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital Cancer Center at Aultman Health Foundation
      • Chillicothe, Ohio, United States, 54601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43215
        • Grant Riverside Cancer Services
      • Columbus, Ohio, United States, 43222
        • Mount Carmel West Hospital
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, United States, 45504
        • Mercy Medical Center Oncology Unit
      • Westerville, Ohio, United States, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital and University Health Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84603
        • Utah Valley Regional Medical Center - Provo
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists at UCS Cancer Center
      • St. George, Utah, United States, 84770
        • Dixie Regional Medical Center
    • Washington
      • Bellingham, Washington, United States, 98225
        • St. Joseph Hospital Community Cancer Center
      • Bremerton, Washington, United States, 98310
        • Olympic Hematology and Oncology
      • Mt. Vernon, Washington, United States, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98195
        • University Cancer Center at University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Group Health Central Hospital
      • Seattle, Washington, United States, 98114
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Sedro-Wooley, Washington, United States, 98284
        • North Puget Oncology at United General Hospital
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Wenatchee, Washington, United States, 98801
        • Central Washington Hospital
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Clinic
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: surgery
Procedure: Surgery
Complete surgical resection of metastatic melanoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1-year
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065130
  • U10CA032102 (U.S. NIH Grant/Contract)
  • SWOG-9430
  • ECOG-S9430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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