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

NCT ID: NCT00006734

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

587 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* Compare the effect of interval-compressed vs standard chemotherapy in terms of event-free survival and overall survival in patients with newly diagnosed, localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 18 years vs 18 years and over) and location of primary disease (pelvic vs nonpelvic). Patients are randomized to 1 of 2 treatment arms for induction and continuation therapy.

* Induction therapy (weeks 1-12):

* Arm I: Patients receive alternating courses of chemotherapy consisting of vincristine IV on day 1, doxorubicin IV continuously over 48 hours on days 1 and 2, and cyclophosphamide IV over 1 hour on day 1 for courses 1 and 3 and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 for courses 2 and 4. Beginning 24 hours after the last dose of chemotherapy for each course, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Treatment continues every 3 weeks for 4 courses.
* Arm II: Patients receive alternating courses of chemotherapy consisting of vincristine, doxorubicin, and cyclophosphamide as in arm I for courses 1, 3, and 5 and ifosfamide and etoposide as in arm I for courses 2, 4, and 6. Patients also receive G-CSF as in arm I. Treatment continues every 2 weeks for 6 courses.

After completion of induction therapy, patients in both arms receive local control treatment to the primary tumor. Patients receive continuation chemotherapy after surgery or concurrently with radiotherapy.

* Continuation therapy:

* Arm I (weeks 13-42): Patients receive additional alternating courses of chemotherapy as in arm I of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 7 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 3 weeks for 10 courses.
* Arm II (weeks 13-29): Patients receive additional alternating courses of chemotherapy as in arm II of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 9 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 2 weeks for 8 courses.

Patients are followed every 3 months for 4 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: Approximately 528 patients will be accrued for this study within 4-5 years.

Conditions

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Sarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regimen A

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.

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

doxorubicin hydrochloride

Intervention Type DRUG

Given IV

etoposide

Intervention Type DRUG

Given IV

ifosfamide

Intervention Type DRUG

Given IV

vincristine sulfate

Intervention Type DRUG

Given IV

adjuvant therapy

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

brachytherapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Regimen B

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.

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

Given IV

cyclophosphamide

Intervention Type DRUG

Given IV

doxorubicin hydrochloride

Intervention Type DRUG

Given IV

etoposide

Intervention Type DRUG

Given IV

ifosfamide

Intervention Type DRUG

Given IV

vincristine sulfate

Intervention Type DRUG

Given IV

adjuvant therapy

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

brachytherapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Interventions

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filgrastim

Given IV

Intervention Type BIOLOGICAL

cyclophosphamide

Given IV

Intervention Type DRUG

doxorubicin hydrochloride

Given IV

Intervention Type DRUG

etoposide

Given IV

Intervention Type DRUG

ifosfamide

Given IV

Intervention Type DRUG

vincristine sulfate

Given IV

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

brachytherapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Other Intervention Names

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GRANULOCYTE COLONY-STIMULATING FACTOR r-metHuG-CSF G-CSF Neupogen NSC 614629 CTX Cytoxan NSC #026271 Adriamycin NSC #123127 IND #7038 VP-16 VePesid Etopophos NSC #141540 Ifex NSC #109724 Oncovin NSC #067574

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B. Womer, MD

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Locations

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Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of South Alabama Cancer Research Institute

Mobile, Alabama, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Southern California Permanente Medical Group

Downey, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

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

Long Beach, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Site Status

Children's Hospital Central California

Madera, California, United States

Site Status

Children's Hospital and Research Center at Oakland

Oakland, California, United States

Site Status

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

Orange, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, United States

Site Status

Children's Hospital and Health Center - San Diego

San Diego, California, United States

Site Status

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, United States

Site Status

Children's Hospital Cancer Center

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

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

Farmington, Connecticut, United States

Site Status

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Site Status

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Lombardi Cancer Center at Georgetown University Medical Center

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

Site Status

Children's National Medical Center

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

Site Status

Broward General Medical Center

Fort Lauderdale, Florida, United States

Site Status

Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Site Status

Joe DiMaggio Children's Hospital at Memorial

Hollywood, Florida, United States

Site Status

Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

Site Status

Florida Hospital Cancer Institute

Orlando, Florida, United States

Site Status

Nemours Children's Clinic-Orlando

Orlando, Florida, United States

Site Status

Sacred Heart Children's Hospital

Pensacola, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, United States

Site Status

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, United States

Site Status

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

Atlanta, Georgia, United States

Site Status

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois Medical Center

Chicago, Illinois, United States

Site Status

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

Site Status

Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Site Status

Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Riley Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

St. Vincent Hospitals and Health Care Centers

Indianapolis, Indiana, United States

Site Status

Blank Children's Hospital

Des Moines, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Site Status

Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Site Status

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Pediatric Specialty Clinic at Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Maine Children's Cancer Program

Scarborough, Maine, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Walter Reed Army Medical Center

Silver Spring, Maryland, United States

Site Status

Floating Hospital for Children

Boston, Massachusetts, United States

Site Status

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

Boston, Massachusetts, United States

Site Status

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

Springfield, Massachusetts, United States

Site Status

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status

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

Detroit, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Site Status

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, United States

Site Status

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

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Sletten Regional Cancer Institute

Great Falls, Montana, United States

Site Status

Children's Hospital of Omaha

Omaha, Nebraska, United States

Site Status

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

St. Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

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

New Brunswick, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, United States

Site Status

Valerie Fund Children's Center at Atlantic Health

Summit, New Jersey, United States

Site Status

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Site Status

Children's Hospital at Albany Medical Center

Albany, New York, United States

Site Status

Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

Site Status

Comprehensive Cancer Center at Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Site Status

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

Rochester, New York, United States

Site Status

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Site Status

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

Chapel Hill, North Carolina, United States

Site Status

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

Greenville, North Carolina, United States

Site Status

Dakota Cancer Institute at Innovis Health - Dakota Clinic

Fargo, North Dakota, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Columbus Children's Hospital

Columbus, Ohio, United States

Site Status

Children's Medical Center - Dayton

Dayton, Ohio, United States

Site Status

Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

Tod Children's Hospital - Forum Health

Youngstown, Ohio, United States

Site Status

Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Site Status

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Site Status

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, United States

Site Status

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, United States

Site Status

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, United States

Site Status

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, United States

Site Status

East Tennessee Children's Hospital

Knoxville, Tennessee, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, United States

Site Status

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status

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

Dallas, Texas, United States

Site Status

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, United States

Site Status

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Site Status

Covenant Children's Hospital

Lubbock, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

MBCCOP - South Texas Pediatrics

San Antonio, Texas, United States

Site Status

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, United States

Site Status

CCOP - Scott and White Hospital

Temple, Texas, United States

Site Status

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, United States

Site Status

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Site Status

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Site Status

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Site Status

INOVA Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Carilion Medical Center for Children at Roanoke Community Hospital

Roanoke, Virginia, United States

Site Status

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, United States

Site Status

Olympic Hematology and Oncology

Bremerton, Washington, United States

Site Status

Cancer Care Center at Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Group Health Central Hospital

Seattle, Washington, United States

Site Status

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Site Status

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

Deaconess Medical Center

Spokane, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Central Washington Hospital

Wenatchee, Washington, United States

Site Status

Wenatchee Valley Clinic

Wenatchee, Washington, United States

Site Status

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

Charleston, West Virginia, United States

Site Status

Cabell Huntington Hospital

Huntington, West Virginia, United States

Site Status

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Bellin Memorial Hospital

Green Bay, Wisconsin, United States

Site Status

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Medical College of Ohio Cancer Institute

Madison, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Site Status

Midwest Children's Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Sydney Children's Hospital

Randwick, New South Wales, Australia

Site Status

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Site Status

Royal Children's Hospital

Brisbane, Queensland, Australia

Site Status

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Site Status

Royal Children's Hospital

Parkville, Victoria, Australia

Site Status

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Site Status

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

Site Status

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Children's Hospital of Western Ontario

London, Ontario, Canada

Site Status

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, Canada

Site Status

Hopital Sainte Justine

Montreal, Quebec, Canada

Site Status

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Starship Children's Health

Auckland, , New Zealand

Site Status

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

San Juan, , Puerto Rico

Site Status

San Jorge Children's Hospital

Santurce, , Puerto Rico

Site Status

Swiss Pediatric Oncology Group Bern

Bern, , Switzerland

Site Status

Swiss Pediatric Oncology Group Geneva

Geneva, , Switzerland

Site Status

Swiss Pediatric Oncology Group Lausanne

Lausanne, , Switzerland

Site Status

Countries

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United States Australia Canada Netherlands New Zealand Puerto Rico Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 20308669 (View on PubMed)

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.

Reference Type RESULT
PMID: 23091096 (View on PubMed)

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.

Reference Type RESULT
PMID: 21480204 (View on PubMed)

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.

Reference Type 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.

Reference Type DERIVED
PMID: 37651654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28787430 (View on PubMed)

Other Identifiers

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COG-AEWS0031

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068323

Identifier Type: OTHER

Identifier Source: secondary_id

A7983

Identifier Type: OTHER

Identifier Source: secondary_id

AEWS0031

Identifier Type: -

Identifier Source: org_study_id

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