Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

NCT00006734 | Completed Phase 3 DMC

• 4 other identifiers: AEWS0031COG-AEWS0031CDR0000068323A7983
• Study Type: interventional
• Target: 587
• Locations: 7 countries
• Sites: 239

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor. PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.

Conditions

Sarcoma

Keywords

localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Assessed using a two sided log rank test of 0.05.

  Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years

Study Arms (2)

Regimen A

EXPERIMENTAL

Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.

Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: brachytherapy; Radiation: radiation therapy

Regimen B

EXPERIMENTAL

Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.

Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: brachytherapy; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Given IV

Also known as: GRANULOCYTE COLONY-STIMULATING FACTOR, r-metHuG-CSF, G-CSF, Neupogen, NSC 614629

Regimen A; Regimen B

cyclophosphamide DRUG

Given IV

Also known as: CTX, Cytoxan, NSC #026271

Regimen A; Regimen B

doxorubicin hydrochloride DRUG

Given IV

Also known as: Adriamycin, NSC #123127, IND #7038

Regimen A; Regimen B

etoposide DRUG

Given IV

Also known as: VP-16, VePesid, Etopophos, NSC #141540

Regimen A; Regimen B

ifosfamide DRUG

Given IV

Also known as: Ifex, NSC #109724

Regimen A; Regimen B

vincristine sulfate DRUG

Given IV

Also known as: Oncovin, NSC #067574

Regimen A; Regimen B

adjuvant therapy PROCEDURE

Regimen A; Regimen B

conventional surgery PROCEDURE

Regimen A; Regimen B

neoadjuvant therapy PROCEDURE

Regimen A; Regimen B

brachytherapy RADIATION

Regimen A; Regimen B

radiation therapy RADIATION

Regimen A; Regimen B

Eligibility Criteria

• Age: 0 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues * Diagnostic biopsy of primary tumor within 30 days of study * Paraspinal or bony skull tumors of extradural origin allowed * No intradural soft tissue tumors * Askin's tumor of the chest wall allowed * Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed * No contralateral pleural effusions * No metastatic disease or distant node involvement * One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis * Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor * Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET * No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma * No esthesioneuroblastoma * Clinically or pathologically involved regional lymph nodes allowed * No CNS involvement PATIENT CHARACTERISTICS: Age: * 50 and under at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine normal for age * Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min Cardiovascular: * Shortening fraction at least 28% by echocardiography OR * Ejection fraction at least 55% by radionuclide angiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for skin cancer * No concurrent sargramostim (GM-CSF) * No concurrent pegfilgrastim Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Prior complete or partial excision of primary tumor allowed

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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (239)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of South Alabama Cancer Research Institute

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801-1428, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Children's Hospital and Health Center - San Diego

San Diego, California, 92123-4282, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Children's Hospital Cancer Center

Denver, Colorado, 80218, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8064, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0296, United States

Location

Joe DiMaggio Children's Hospital at Memorial

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176-2197, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Nemours Children's Clinic-Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Children's Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33677-4227, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

Atlanta, Georgia, 30342, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31405, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60601, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9658, United States

Location

Riley Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

St. Vincent Hospitals and Health Care Centers

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50308, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0284, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202-3830, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Pediatric Specialty Clinic at Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074-9308, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201-1595, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-7223, United States

Location

Walter Reed Army Medical Center

Silver Spring, Maryland, 20910, United States

Location

Floating Hospital for Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, 01107, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007-5364, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073-6769, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Children's Hospitals and Clinics - Minneapolis/St. Paul

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

Children's Hospital of Omaha

Omaha, Nebraska, 68114, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-2168, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112-2094, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Valerie Fund Children's Center at Atlantic Health

Summit, New Jersey, 07901, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Children's Hospital at Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201-5493, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Comprehensive Cancer Center at Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794-8174, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

Greenville, North Carolina, 27858-4354, United States

Location

Dakota Cancer Institute at Innovis Health - Dakota Clinic

Fargo, North Dakota, 58103-4940, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43601, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-1320, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105-1080, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37614-0622, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-6310, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9063, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

MBCCOP - South Texas Pediatrics

San Antonio, Texas, 78229-3900, United States

Location

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229-3902, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-5100, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0212, United States

Location

Carilion Medical Center for Children at Roanoke Community Hospital

Roanoke, Virginia, 24029, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Cancer Care Center at Skagit Valley Hospital

Mount Vernon, Washington, 98273, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98114, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-0001, United States

Location

Central Washington Hospital

Wenatchee, Washington, 98801, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, 25302, United States

Location

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-9070, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Medical College of Ohio Cancer Institute

Madison, Wisconsin, 53792-6164, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449-5772, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Brisbane, Queensland, 4029, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8S 4J9, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Starship Children's Health

Auckland, New Zealand

Location

Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Swiss Pediatric Oncology Group Geneva

Geneva, CH 1211, Switzerland

Location

Swiss Pediatric Oncology Group Lausanne

Lausanne, CH 1011, Switzerland

Location

Related Publications (6)

• van Doorninck JA, Ji L, Schaub B, Shimada H, Wing MR, Krailo MD, Lessnick SL, Marina N, Triche TJ, Sposto R, Womer RB, Lawlor ER. Current treatment protocols have eliminated the prognostic advantage of type 1 fusions in Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2010 Apr 20;28(12):1989-94. doi: 10.1200/JCO.2009.24.5845. Epub 2010 Mar 22.

  PMID: 20308669 BACKGROUND

• Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, Weiss AR. Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-54. doi: 10.1200/JCO.2011.41.5703. Epub 2012 Oct 22.

  PMID: 23091096 RESULT

• Borinstein SC, Barkauskas DA, Krailo M, Scher D, Scher L, Schlottmann S, Kallakury B, Dickman PS, Pawel BR, West DC, Womer RB, Toretsky JA. Investigation of the insulin-like growth factor-1 signaling pathway in localized Ewing sarcoma: a report from the Children's Oncology Group. Cancer. 2011 Nov 1;117(21):4966-76. doi: 10.1002/cncr.26112. Epub 2011 Apr 8.

  PMID: 21480204 RESULT

• Womer RB, West DC, Krailo MD, et al.: Randomized comparison of every-two-week v. every-three-week chemotherapy in Ewing sarcoma family tumors (ESFT). [Abstract] J Clin Oncol 26 (Suppl 15): A-10504, 2008.

  RESULT

• Cash T, Krailo MD, Buxton AB, Pawel BR, Healey JH, Binitie O, Marcus KJ, Grier HE, Grohar PJ, Reed DR, Weiss AR, Gorlick R, Janeway KA, DuBois SG, Womer RB. Long-Term Outcomes in Patients With Localized Ewing Sarcoma Treated With Interval-Compressed Chemotherapy on Children's Oncology Group Study AEWS0031. J Clin Oncol. 2023 Oct 20;41(30):4724-4728. doi: 10.1200/JCO.23.00053. Epub 2023 Aug 31.

  PMID: 37651654 DERIVED

• Mora J, Castaneda A, Perez-Jaume S, Lopez-Pousa A, Maradiegue E, Valverde C, Martin-Broto J, Garcia Del Muro X, Cruz O, Cruz J, Martinez-Trufero J, Maurel J, Vaz MA, de Alava E, de Torres C. GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS). Br J Cancer. 2017 Sep 5;117(6):767-774. doi: 10.1038/bjc.2017.252. Epub 2017 Aug 8.

  PMID: 28787430 DERIVED

MeSH Terms

Conditions

Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Cyclophosphamide; Doxorubicin; Etoposide; etoposide phosphate; Ifosfamide; Vincristine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Richard B. Womer, MD

  Children's Hospital of Philadelphia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: August 1, 2006
• Study Completion: June 30, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CA (14); US (212); AU (6); NZ (1); PR (2); CH (3); NL (1)