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Melanoma (Skin)Phase 2NCT00002860

SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

A Phase 2 study testing Surgery in people with Melanoma (Skin), run by SWOG Cancer Research Network at 124 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
124 sitesUnited States
Study dates
Nov 1996to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

124 sites in 1 country.

124 sites in 1 country

United States124 sites

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Adena Regional Medical Center

    Chillicothe, Ohio, 54601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazooaa, Michigan, 49001

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Kansas, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Logan Regional Hospital

    Logan, Utah, 84321

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Fox Chase Virtua Health Cancer Program - Marlton

    Marlton, New Jersey, 08053

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • Banner Thunderbird Medical Center

    Phoenix, Arizona, 85306

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84603

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Mercy Medical Center Oncology Unit

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Melanoma (Skin)
Being tested
Surgery
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Complete surgical resection of metastatic melanoma

Study groups in NCT00002860
Study groupRoleWhat they receive
surgeryOtherNot described
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1996
  3. Primary completionDec 2006
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002860
Sponsor's protocol ID
CDR0000065130
Other IDs
U10CA032102, SWOG-9430, ECOG-S9430
Status last verified
Jan 2012
First submitted
1 Nov 1999
Last updated
13 Jan 2012
Results posted
No
Data monitoring committee
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery in people with Melanoma (Skin), run by SWOG Cancer Research Network at 124 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.

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