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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 1996

Longer than P75 for phase_2

Geographic Reach

1 country

124 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14.1 years study duration

Study Start

First participant enrolled

November 1, 1996

Completed

3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

10.1 years

First QC Date

November 1, 1999

Last Update Submit

January 11, 2012

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (1)

Overall survival
1-year

Study Arms (1)

surgery

OTHER

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Complete surgical resection of metastatic melanoma

surgery

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator
Eastern Cooperative Oncology Groupcollaborator

Study Sites (124)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006, United States

Location

Banner Thunderbird Medical Center

Phoenix, Arizona, 85306, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

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

Alton, Illinois, 62002, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101-1733, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

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

El Dorado, Kansas, 67042, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Kansas, 64128, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

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

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium