Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

NCT ID: NCT00020566

Last Updated: 2014-06-24

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Brief Summary

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RATIONALE: Drugs used in chemotherapy use 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Detailed Description

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OBJECTIVES:

Primary

* Compare the event-free and overall survival of patients with tumor of the Ewing's family treated with standard induction chemotherapy comprising vincristine, dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC) transplantation with or without radiotherapy and/or surgery.

Secondary

* Determine the prognostic significance of EWS-Flil transcript in these patients.
* Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC, as determined by the presence or absence of EWS-Flil transcript, in these patients.
* Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients.
* Determine the response of these patients to VIDE induction chemotherapy.
* Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients.
* Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients.
* Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and local treatment of the primary tumor (yes vs no).

Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE). Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain and/or spinal cord (at any time during study) are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2.

* Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.
* Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2 consolidation therapy arms.

* Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
* Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.

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

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within approximately 7 years.

Conditions

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Sarcoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Study Groups

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Group 1

Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.

Group Type EXPERIMENTAL

dactinomycin

Intervention Type BIOLOGICAL

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

conventional surgery

Intervention Type PROCEDURE

Given to patients deemed to require it

radiation therapy

Intervention Type RADIATION

Given to patients deemed to require it

Group 2, arm I

Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.

Group Type EXPERIMENTAL

dactinomycin

Intervention Type BIOLOGICAL

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

conventional surgery

Intervention Type PROCEDURE

Given to patients deemed to require it

radiation therapy

Intervention Type RADIATION

Given to patients deemed to require it

Group 2, arm II

Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.

Group Type EXPERIMENTAL

dactinomycin

Intervention Type BIOLOGICAL

Given IV

busulfan

Intervention Type DRUG

Given orally and IV

doxorubicin hydrochloride

Intervention Type DRUG

Given IV

etoposide

Intervention Type DRUG

Given IV

ifosfamide

Intervention Type DRUG

Given IV

melphalan

Intervention Type DRUG

Given orally and IV

vincristine sulfate

Intervention Type DRUG

Given IV

autologous hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Given IV

conventional surgery

Intervention Type PROCEDURE

Given to patients deemed to require it

radiation therapy

Intervention Type RADIATION

Given to patients deemed to require it

Interventions

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dactinomycin

Given IV

Intervention Type BIOLOGICAL

busulfan

Given orally and IV

Intervention Type DRUG

doxorubicin hydrochloride

Given IV

Intervention Type DRUG

etoposide

Given IV

Intervention Type DRUG

ifosfamide

Given IV

Intervention Type DRUG

melphalan

Given orally and IV

Intervention Type DRUG

vincristine sulfate

Given IV

Intervention Type DRUG

autologous hematopoietic stem cell transplantation

Given IV

Intervention Type PROCEDURE

conventional surgery

Given to patients deemed to require it

Intervention Type PROCEDURE

radiation therapy

Given to patients deemed to require it

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed tumor of the Ewing's family of bone or soft tissue

* Ewing's sarcoma
* Peripheral primitive neuroectodermal tumor
* Disease meeting one of the following criteria:

* Resectable localized disease (tumor volume less than 200 mL)
* Localized disease previously resected at diagnosis
* Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed
* Localized disease with early radiotherapy required
* Pulmonary and/or pleural metastases only
* Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
* No more than 45 days since definitive biopsy

PATIENT CHARACTERISTICS:

Age:

* Under 50

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Renal function normal
* Glomerular filtration rate at least 60 mL/min

Cardiovascular:

* Normal cardiac function
* Fractional shortening at least 29%
* Ejection fraction at least 40%

Other:

* No medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Cancer and Leukaemia Group

OTHER

Sponsor Role collaborator

Societe Francaise Oncologie Pediatrique

OTHER

Sponsor Role collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

Sponsor Role collaborator

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria

OTHER

Sponsor Role collaborator

Swiss Cancer Institute

OTHER

Sponsor Role collaborator

EBMT Solid Tumors Working Party

OTHER

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role lead

Principal Investigators

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Alan W. Craft, MD

Role: STUDY_CHAIR

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Ian J. Lewis, MD

Role: STUDY_CHAIR

Leeds Cancer Centre at St. James's University Hospital

Odile Oberlin, MD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Ian R. Judson, MA, MD, FRCP

Role:

Institute of Cancer Research, United Kingdom

Heribert F. Juergens, MD

Role: STUDY_CHAIR

University Hospital Muenster

Helmut Gadner, MD, FRCPG

Role: STUDY_CHAIR

St. Anna Kinderkrebsforschung

G. Ulrich Exner, MD

Role: STUDY_CHAIR

Balgrist Universitaetsklinik

Ruth Ladenstein, MD

Role: STUDY_CHAIR

St. Anna Kinderkrebsforschung

Douglas Hawkins, MD

Role: STUDY_CHAIR

Seattle Children's Hospital

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center - Oakland

Sacramento, California, United States

Site Status RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado Center for Cancer and Blood Disorders

Aurora, Colorado, United States

Site Status RECRUITING

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

Children's National Medical Center

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

Site Status RECRUITING

Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Orlando

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Site Status RECRUITING

All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, United States

Site Status RECRUITING

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, United States

Site Status RECRUITING

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

Atlanta, Georgia, United States

Site Status RECRUITING

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status RECRUITING

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status RECRUITING

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status RECRUITING

Simmons Cooper Cancer Institute

Springfield, Illinois, United States

Site Status RECRUITING

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

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

Boston, Massachusetts, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

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

Grosse Pointe Woods, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status RECRUITING

CCOP - Duluth

Duluth, Minnesota, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Site Status RECRUITING

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - St. Paul

Saint Paul, Minnesota, United States

Site Status RECRUITING

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States

Site Status RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status RECRUITING

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

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

Rochester, New York, United States

Site Status RECRUITING

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status RECRUITING

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status RECRUITING

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status RECRUITING

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke Cancer Institute

Durham, North Carolina, United States

Site Status RECRUITING

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Dayton Children's - Dayton

Dayton, Ohio, United States

Site Status RECRUITING

Toledo Hospital

Toledo, Ohio, United States

Site Status RECRUITING

Tod Children's Hospital

Youngstown, Ohio, United States

Site Status RECRUITING

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Greenville Hospital Cancer Center

Greenville, South Carolina, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

East Tennessee Children's Hospital

Knoxville, Tennessee, United States

Site Status RECRUITING

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Amarillo, Texas, United States

Site Status RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status RECRUITING

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

Dallas, Texas, United States

Site Status RECRUITING

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Site Status RECRUITING

Primary Children's Medical Center

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Site Status RECRUITING

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, United States

Site Status RECRUITING

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, United States

Site Status RECRUITING

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, United States

Site Status RECRUITING

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, United States

Site Status RECRUITING

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status RECRUITING

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status RECRUITING

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Site Status RECRUITING

Royal Children's Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Site Status RECRUITING

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Children's and Women's Hospital of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

Hopital Sainte Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Site Status RECRUITING

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Starship Children's Health

Auckland, , New Zealand

Site Status RECRUITING

San Jorge Children's Hospital

Santurce, , Puerto Rico

Site Status RECRUITING

Countries

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United States Australia Canada New Zealand Puerto Rico

Facility Contacts

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Clinical Trials Office - UAB Comprehensive Cancer Center

Role: primary

205-934-0309

Jessica Boklan

Role: primary

602-546-0920

Clinical Trial Office - Arkansas Cancer Research Center at Uni

Role: primary

501-686-8274

Clinical Trials Office - City of Hope Comprehensive Cancer Cen

Role: primary

800-826-4673

Leo Mascarenhas

Role: primary

323-361-2529

Robert M. Cooper

Role: primary

323-783-5307

Neyssa M. Marina

Role: primary

650-723-5535

Vincent A. Kiley

Role: primary

916-474-2326

Clinical Trials Office - Rady Children's Hospital - San Diego

Role: primary

858-966-5934

Clinical Trials Office - UCSF Helen Diller Family Comprehensi

Role: primary

877-827-3222

Kelly W. Maloney

Role: primary

720-777-6673

Clinical Trials Office - Alfred I. duPont Hospital for Childre

Role: primary

302-651-5755

Clinical Trials Office - Children's National Medical Center

Role: primary

202-884-2549

Eric S. Sandler

Role: primary

904-697-3793

University of Miami Sylvester Comprehensive Cancer Center Clin

Role: primary

866-574-5124

Ramamoorthy Nagasubramanian

Role: primary

407-650-7230

Jeffrey H. Schwartz

Role: primary

850-505-4790

Gregory A. Hale

Role: primary

727-767-4176

Clinical Trials Office - St. Joseph's Cancer Institute

Role: primary

800-882-4123

Narayana Gowda

Role: primary

561-844-6363

Todd M. Cooper

Role: primary

404-785-1838

Clinical Trials Office - Cancer Research Center of Hawaii

Role: primary

808-586-2979

Eugenia Chang

Role: primary

208-381-2731

Clinical Trials Office - University of Chicago Cancer Research

Role: primary

773-834-7424

Pedro A. De Alarcon

Role: primary

309-655-4242

Clinical Trials Office - Simmons Cooper Cancer Institute

Role: primary

217-545-7929

Cancer Information Service

Role: primary

800-237-1225

Clinical Trials Office - Kosair Children's Hospital

Role: primary

502-629-5500

Clinical Trials Office - Children's Hospital of New Orleans

Role: primary

504-894-5377

Joseph M. Wiley

Role: primary

410-601-6266

Carlos Rodriguez-Galindo

Role: primary

617-632-4580

Clinical Trials Office - Hurley Medical Center

Role: primary

810-762-8057

Clinical Trials Office - Helen DeVos Children's Hospital

Role: primary

616-391-3050

Clincial Trials Office - Van Elslander Cancer Center at St. Jo

Role: primary

313-343-3166

Jeffrey S. Lobel

Role: primary

269-341-6350

Clinical Trials Office - Breslin Cancer Center at Ingham Regio

Role: primary

517-334-2765

Contact Person

Role: primary

218-786-8364

Clinical Trials Office - Children's Hospitals and Clinics of M

Role: primary

612-813-5193

Clinical Trials Office - Masonic Cancer Center at University o

Role: primary

612-624-2620

Clinical Trials Office - All Mayo Clinic Locations

Role: primary

507-538-7623

Contact Person

Role: primary

612-220-6000

Gail C. Megason

Role: primary

601-984-5220

Maxine L. Hetherington

Role: primary

816-234-3265

Robert J. Hayashi

Role: primary

314-454-2041

Jonathan Bernstein

Role: primary

702-732-1493

Clinical Trials Office - Hackensack University Medical Center

Role: primary

201-996-2879

Clinical Trials Office - Roswell Park Cancer Institute

Role: primary

877-275-7724

Clinical Trials Office - Herbert Irving Comprehensive Cancer C

Role: primary

212-305-8615

Lisa R. Hackney

Role: primary

585-275-2981

Clinical Trials Office - SUNY Upstate Medical University Hospi

Role: primary

315-464-5476

Clinical Trials Office - Albert Einstein Cancer Center at Albe

Role: primary

718-904-2730

Clinical Trials Office - Blumenthal Cancer Center at Carolinas

Role: primary

704-355-2884

Clinical Trials Office - Presbyterian Cancer Center at Presbyt

Role: primary

704-384-5369

Clinical Trials Office - Duke Cancer Institute

Role: primary

888-275-3853

Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M

Role: primary

252-744-2391

Clinical Trials Office - Cincinnati Children's Hospital Medica

Role: primary

513-636-2799

Yousif (Joe) H. Matloub

Role: primary

216-844-3345

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

Role: primary

866-223-8100

Laura T. Martin

Role: primary

614-722-3582

Emmett H. Broxson

Role: primary

937-641-3111

Clinical Trials Office - Toledo Hospital

Role: primary

419-824-1842

Clinical Trials Office - Tod Children's Hospital

Role: primary

330-884-3955

Rene Y. McNall-Knapp

Role: primary

405-271-5311

Clinical Trials Office - Legacy Emanuel Children's Hospital

Role: primary

503-413-2560

Philip M. Monteleone

Role: primary

484-884-3333

John F. Kuttesch

Role: primary

717-531-6012

Elizabeth Fox

Role: primary

267-425-3010

Clinical Trials Office - Children's Hospital of Pittsburgh

Role: primary

412-692-7056

Clinical Trials Office - Greenville Hospital Cancer Center

Role: primary

864-241-6251

Contact Person

Role: primary

605-322-3000

Ray C. Pais

Role: primary

865-541-8266

Osvaldo Regueira

Role: primary

806-354-5434x282

Clinical Trials Office - Driscoll Children's Hospital

Role: primary

361-694-5311

Clinical Trials Office - Simmons Comprehensive Cancer Center a

Role: primary

866-460-4673; 214-648-7097

Clinical Trials Office - Cook's Children's Medical Center

Role: primary

682-885-2103

Anne-Marie R. Langevin

Role: primary

210-567-7477

Jaime Estrada

Role: primary

210-575-7268

Phillip E. Barnette

Role: primary

801-662-4700

Kimberly P. Dunsmore

Role: primary

434-924-5105

Clinical Trials Office - Inova Fairfax Hospital

Role: primary

703-208-6650

Eric J. Lowe

Role: primary

757-668-7243

Julie R. Park

Role: primary

206-987-2106

Judy L. Felgenhauer

Role: primary

509-474-2777

Robert G. Irwin

Role: primary

253-403-3481

Allen R. Chauvenet

Role: primary

304-388-1552

Clinical Trials Office - St. Vincent Hospital Regional Cancer

Role: primary

920-433-8889

Clinical Trials Office - Marshfield Clinic - Marshfield Center

Role: primary

800-782-1581 ext. 94457

Michael E. Kelly

Role: primary

414-456-4170

Geoffrey B. McCowage

Role: primary

61298452122

Helen Irving

Role: primary

617-3636-8671

Maria L. Kirby

Role: primary

61881617411

Catherine H. Cole

Role: primary

011-6189340-8238

Sunil Jayantilal' S. Desai

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780-248-5530

Caron Strahlendorf

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604-875-3576

Rochelle A. Yanofsky

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204-787-4163

Lisa Anne B. Goodyear

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709-777-4303

Margaret C. Yhap

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902-470-8778

Sylvain Baruchel

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416-813-7795

Yvan Samson

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514-345-4931x2790

Bruno Michon

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418-656-4141X47191

Christopher Mpofu

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306-655-2744

Lochie R. Teague

Role: primary

649-307-4949x22423

Luis A. Clavell

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787-728-1575

References

Explore related publications, articles, or registry entries linked to this study.

Ladenstein R, Potschger U, Le Deley MC, Whelan J, Paulussen M, Oberlin O, van den Berg H, Dirksen U, Hjorth L, Michon J, Lewis I, Craft A, Jurgens H. Primary disseminated multifocal Ewing sarcoma: results of the Euro-EWING 99 trial. J Clin Oncol. 2010 Jul 10;28(20):3284-91. doi: 10.1200/JCO.2009.22.9864. Epub 2010 Jun 14.

Reference Type RESULT
PMID: 20547982 (View on PubMed)

Le Deley MC, Delattre O, Schaefer KL, Burchill SA, Koehler G, Hogendoorn PC, Lion T, Poremba C, Marandet J, Ballet S, Pierron G, Brownhill SC, Nesslbock M, Ranft A, Dirksen U, Oberlin O, Lewis IJ, Craft AW, Jurgens H, Kovar H. Impact of EWS-ETS fusion type on disease progression in Ewing's sarcoma/peripheral primitive neuroectodermal tumor: prospective results from the cooperative Euro-E.W.I.N.G. 99 trial. J Clin Oncol. 2010 Apr 20;28(12):1982-8. doi: 10.1200/JCO.2009.23.3585. Epub 2010 Mar 22.

Reference Type RESULT
PMID: 20308673 (View on PubMed)

Juergens C, Weston C, Lewis I, Whelan J, Paulussen M, Oberlin O, Michon J, Zoubek A, Juergens H, Craft A. Safety assessment of intensive induction with vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) in the treatment of Ewing tumors in the EURO-E.W.I.N.G. 99 clinical trial. Pediatr Blood Cancer. 2006 Jul;47(1):22-9. doi: 10.1002/pbc.20820.

Reference Type RESULT
PMID: 16572419 (View on PubMed)

Stork T, Ranft A, Aigner C, Jurgens H, Ladenstein RL, Timmermann B, Van den Berg H, Dirksen U, Collaud S. Primary Mediastinal Ewing's Sarcoma: Post Hoc Analysis from Two International Multicenter Prospective Randomized Trials. Cancers (Basel). 2025 Jan 2;17(1):118. doi: 10.3390/cancers17010118.

Reference Type DERIVED
PMID: 39796745 (View on PubMed)

Rechl V, Ranft A, Bhadri V, Brichard B, Collaud S, Cyprova S, Eich H, Ek T, Gelderblom H, Hardes J, Haveman LM, Hartmann W, Hauser P, Heesen P, Jurgens H, Kanerva J, Kuhne T, Raciborska A, Rascon J, Streitburger A, Uhlenbruch Y, Timmermann B, Kersting J, Pham MT, Dirksen U. Factors Influencing the Outcome of Patients with Primary Ewing Sarcoma of the Sacrum. Sarcoma. 2024 Mar 16;2024:4751914. doi: 10.1155/2024/4751914. eCollection 2024.

Reference Type DERIVED
PMID: 38524902 (View on PubMed)

Corvest V, Marec-Berard P, Lervat C, Pacquement H, Toulmonde M, Gentet JC, Laurence V, Cleirec M, Mansuy L, Bompas E, Castex MP, Taque S, Filhon B, Tabone MD, Verite C, Entz-Werle N, Saumet L, Guimard G, Pondrom M, Chevreau C, Flandrin J, Duranteau L, Rousset-Jablonski C, Brugieres L, Jimenez M, Le Deley MC, Gaspar N, Fresneau B. Late toxicity comparison of alkylating-based maintenance regimen with cyclophosphamide (VAC) vs ifosfamide (VAI) in Ewing sarcoma survivors treated in the randomized clinical trial Euro-EWING99-R1 in France. Int J Cancer. 2023 Apr 15;152(8):1659-1667. doi: 10.1002/ijc.34326. Epub 2022 Oct 31.

Reference Type DERIVED
PMID: 36250317 (View on PubMed)

Dirksen U, Brennan B, Le Deley MC, Cozic N, van den Berg H, Bhadri V, Brichard B, Claude L, Craft A, Amler S, Gaspar N, Gelderblom H, Goldsby R, Gorlick R, Grier HE, Guinbretiere JM, Hauser P, Hjorth L, Janeway K, Juergens H, Judson I, Krailo M, Kruseova J, Kuehne T, Ladenstein R, Lervat C, Lessnick SL, Lewis I, Linassier C, Marec-Berard P, Marina N, Morland B, Pacquement H, Paulussen M, Randall RL, Ranft A, Le Teuff G, Wheatley K, Whelan J, Womer R, Oberlin O, Hawkins DS; Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators. High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008. J Clin Oncol. 2019 Dec 1;37(34):3192-3202. doi: 10.1200/JCO.19.00915. Epub 2019 Sep 25.

Reference Type DERIVED
PMID: 31553693 (View on PubMed)

Le Deley MC, Paulussen M, Lewis I, Brennan B, Ranft A, Whelan J, Le Teuff G, Michon J, Ladenstein R, Marec-Berard P, van den Berg H, Hjorth L, Wheatley K, Judson I, Juergens H, Craft A, Oberlin O, Dirksen U. Cyclophosphamide compared with ifosfamide in consolidation treatment of standard-risk Ewing sarcoma: results of the randomized noninferiority Euro-EWING99-R1 trial. J Clin Oncol. 2014 Aug 10;32(23):2440-8. doi: 10.1200/JCO.2013.54.4833. Epub 2014 Jun 30.

Reference Type DERIVED
PMID: 24982464 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EURO-EWING-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

EBMT-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

EORTC-62981

Identifier Type: -

Identifier Source: secondary_id

GPOH-AUSTRIA-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

GPOH-GERMANY-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

SFOP-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

SWS-SAKK-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

CCLG-INTERGROUP-EE99

Identifier Type: -

Identifier Source: secondary_id

COG-AEWS0331

Identifier Type: -

Identifier Source: secondary_id

EU-20213

Identifier Type: -

Identifier Source: secondary_id

CDR0000068608

Identifier Type: -

Identifier Source: org_study_id

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