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Completed Phase 3 Interventional Results available

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

ClinicalTrials.gov ID: NCT00346164

Public ClinicalTrials.gov record NCT00346164. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 5:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Study identification

NCT ID
NCT00346164
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
588 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 29 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 5, 2007 (Actual)
Primary completion
Sep 5, 2014 (Actual)
Completion
Mar 31, 2022 (Actual)
Last update posted
Apr 28, 2022

2007 – 2022

United States locations

U.S. sites
165
U.S. states
47
U.S. cities
136
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Phoenix Childrens Hospital Phoenix Arizona 85016 —
University of Arizona Health Sciences Center Tucson Arizona 85724 —
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Children's Oncology Group Arcadia California 91006-3776 —
Southern California Permanente Medical Group Downey California 90242 —
City of Hope Medical Center Duarte California 91010 —
Loma Linda University Medical Center Loma Linda California 92354 —
Miller Children's Hospital Long Beach California 90806 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
David Geffen School of Medicine at UCLA Los Angeles California 90095 —
Children's Hospital Central California Madera California 93636-8762 —
Children's Hospital and Research Center at Oakland Oakland California 94609-1809 —
Kaiser Permanente-Oakland Oakland California 94611 —
Childrens Hospital of Orange County Orange California 92868-3874 —
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304 —
Rady Children's Hospital - San Diego San Diego California 92123 —
University of California San Francisco Medical Center-Parnassus San Francisco California 94143 —
Children's Hospital Colorado Aurora Colorado 80045 —
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Yale University New Haven Connecticut 06520-8032 —
Alfred I duPont Hospital for Children Wilmington Delaware 19803 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Broward Health Medical Center Fort Lauderdale Florida 33316 —
Lee Memorial Health System Fort Myers Florida 33901 —
University of Florida Gainesville Florida 32610 —
Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood Florida 33021 —
Nemours Children's Clinic - Jacksonville Jacksonville Florida 32207-8426 —
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 —
Miami Children's Hospital Miami Florida 33155 —
Baptist Hospital of Miami Miami Florida 33176 —
Florida Hospital Orlando Florida 32803 —
M D Anderson Cancer Center- Orlando Orlando Florida 32806 —
Nemours Childrens Clinic - Orlando Orlando Florida 32806 —
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 —
All Children's Hospital St. Petersburg Florida 33701 —
Saint Joseph Children's Hospital of Tampa Tampa Florida 33607 —
Saint Mary's Hospital West Palm Beach Florida 33407 —
Children's Healthcare of Atlanta - Egleston Atlanta Georgia 30322 —
Memorial Health University Medical Center Savannah Georgia 31403 —
University of Hawaii Honolulu Hawaii 96813 —
Tripler Army Medical Center Honolulu Hawaii 96859 —
Saint Luke's Mountain States Tumor Institute Boise Idaho 83712 —
University of Illinois Chicago Illinois 60612 —
Childrens Memorial Hospital Chicago Illinois 60614 —
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637-1470 —
Loyola University Medical Center Maywood Illinois 60153 —
Advocate Hope Children's Hospital Oak Lawn Illinois 60453 —
Advocate Lutheran General Hospital Park Ridge Illinois 60068 —
Saint Jude Midwest Affiliate Peoria Illinois 61602 —
Southern Illinois University Springfield Illinois 62702 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Saint Vincent Hospital and Health Services Indianapolis Indiana 46260 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
University of Kentucky Lexington Kentucky 40536 —
Kosair Children's Hospital Louisville Kentucky 40202 —
Tulane University Health Sciences Center New Orleans Louisiana 70112 —
Eastern Maine Medical Center Bangor Maine 04401 —
Maine Children's Cancer Program Scarborough Maine 04074 —
University of Maryland Greenebaum Cancer Center Baltimore Maryland 21201-1595 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Johns Hopkins University Baltimore Maryland 21287-8936 —
Walter Reed National Military Medical Center Bethesda Maryland 20889-5600 —
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114 —
Dana-Farber Cancer Institute Boston Massachusetts 02115 —
University of Massachusetts Medical School Worcester Massachusetts 01655 —
C S Mott Children's Hospital Ann Arbor Michigan 48109 —
Wayne State University Detroit Michigan 48202 —
Saint John Hospital and Medical Center Detroit Michigan 48236 —
Hurley Medical Center Flint Michigan 48502 —
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan 49503 —
Kalamazoo Center for Medical Studies Kalamazoo Michigan 49008 —
Michigan State University - Breslin Cancer Center Lansing Michigan 48910 —
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 —
University of Minnesota Medical Center-Fairview Minneapolis Minnesota 55455 —
Mayo Clinic Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
University of Missouri-Columbia Columbia Missouri 65212 —
The Childrens Mercy Hospital Kansas City Missouri 64108 —
Washington University School of Medicine St Louis Missouri 63110 —
Saint John's Mercy Medical Center St Louis Missouri 63141 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Nevada Cancer Research Foundation CCOP Las Vegas Nevada 89106 —
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Saint Peter's University Hospital New Brunswick New Jersey 08901 —
UMDNJ - Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 —
Overlook Hospital Summit New Jersey 07902 —
University of New Mexico Cancer Center Albuquerque New Mexico 87106 —
Albany Medical Center Albany New York 12208 —
Brooklyn Hospital Center Brooklyn New York 11201 —
Roswell Park Cancer Institute Buffalo New York 14263 —
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040 —
New York University Langone Medical Center New York New York 10016 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
University of Rochester Rochester New York 14642 —
Stony Brook University Medical Center Stony Brook New York 11794 —
State University of New York Upstate Medical University Syracuse New York 13210 —
Montefiore Medical Center The Bronx New York 10467-2490 —
New York Medical College Valhalla New York 10595 —
Mission Hospitals Inc Asheville North Carolina 28801 —
University of North Carolina Chapel Hill North Carolina 27599 —
Carolinas Medical Center Charlotte North Carolina 28203 —
Presbyterian Hospital Charlotte North Carolina 28204 —
Duke University Medical Center Durham North Carolina 27710 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Sanford Medical Center-Fargo Fargo North Dakota 58122 —
Children's Hospital Medical Center of Akron Akron Ohio 44308 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Nationwide Children's Hospital Columbus Ohio 43205 —
The Children's Medical Center of Dayton Dayton Ohio 45404 —
The Toledo Hospital/Toledo Children's Hospital Toledo Ohio 43606 —
Mercy Children's Hospital Toledo Ohio 43608 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Legacy Emanuel Children's Hospital Portland Oregon 97227 —
Legacy Emanuel Hospital and Health Center Portland Oregon 97227 —
Oregon Health and Science University Portland Oregon 97239 —
Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania 18017 —
Geisinger Medical Center Danville Pennsylvania 17822-2001 —
Penn State Hershey Children's Hospital Hershey Pennsylvania 17033 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
Rhode Island Hospital Providence Rhode Island 02903 —
Palmetto Health Richland Columbia South Carolina 29203 —
Greenville Cancer Treatment Center Greenville South Carolina 29605 —
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 —
T C Thompson Children's Hospital Chattanooga Tennessee 37403 —
East Tennessee Childrens Hospital Knoxville Tennessee 37916 —
St. Jude Children's Research Hospital Memphis Tennessee 38105 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
Texas Tech University Health Science Center-Amarillo Amarillo Texas 79106 —
Dell Children's Medical Center of Central Texas Austin Texas 78723 —
Driscoll Children's Hospital Corpus Christi Texas 78411 —
Medical City Dallas Hospital Dallas Texas 75230 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Brooke Army Medical Center Fort Sam Houston Texas 78234 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Baylor College of Medicine Houston Texas 77030 —
M D Anderson Cancer Center Houston Texas 77030 —
Covenant Children's Hospital Lubbock Texas 79410 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229-3900 —
Methodist Children's Hospital of South Texas San Antonio Texas 78229 —
Scott and White Memorial Hospital Temple Texas 76508 —
Primary Children's Medical Center Salt Lake City Utah 84113 —
University of Vermont Burlington Vermont 05401 —
University of Virginia Charlottesville Virginia 22908 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Childrens Hospital-King's Daughters Norfolk Virginia 23507 —
Virginia Commonwealth University Richmond Virginia 23298 —
Seattle Children's Hospital Seattle Washington 98105 —
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 —
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 —
Madigan Army Medical Center Tacoma Washington 98431 —
West Virginia University Charleston Charleston West Virginia 25304 —
Saint Vincent Hospital Green Bay Wisconsin 54301 —
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 —
Marshfield Clinic Marshfield Wisconsin 54449 —
Midwest Children's Cancer Center Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00346164, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 28, 2022 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00346164 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →