AzTrials
AzTrials

SarcomaPhase 3NCT00020566

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

A Phase 3 study testing dactinomycin, busulfan and doxorubicin hydrochloride in people with Sarcoma, run by University of Leicester at 103 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 49 years
Conditions the study is for
Sarcoma
What is being tested?
dactinomycin, busulfan and doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
103 sitesin 5 countries
Study dates
Feb 2001to Dec 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 49 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

103 sites in 5 countries.

103 sites in 5 countries

United States88 sites, 88 recruiting

  • Texas Tech University Health Sciences Center School of Medicine - Amarillo

    Amarillo, Texas, 79106

    Osvaldo Regueira, 806-354-5434x282

    Recruiting

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

    Atlanta, Georgia, 30322

    Todd M. Cooper, 404-785-1838

    Recruiting

  • Children's Hospital Colorado Center for Cancer and Blood Disorders

    Aurora, Colorado, 80045

    Kelly W. Maloney, 720-777-6673

    Recruiting

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

    Joseph M. Wiley, 410-601-6266

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Philip M. Monteleone, 484-884-3333

    Recruiting

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

    Clinical Trials Office - UAB Comprehensive Cancer Center, 205-934-0309

    Recruiting

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

    Boise, Idaho, 83712-6297

    Eugenia Chang, 208-381-2731

    Recruiting

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

    Boston, Massachusetts, 2115

    Carlos Rodriguez-Galindo, 617-632-4580

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

    Clinical Trials Office - Roswell Park Cancer Institute, 877-275-7724

    Recruiting

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25302

    Allen R. Chauvenet, 304-388-1552

    Recruiting

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

    Clinical Trials Office - Blumenthal Cancer Center at Carolinas, 704-355-2884

    Recruiting

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

    Clinical Trials Office - Presbyterian Cancer Center at Presbyt, 704-384-5369

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Kimberly P. Dunsmore, 434-924-5105

    Recruiting

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

    Clinical Trials Office - University of Chicago Cancer Research, 773-834-7424

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

    Clinical Trials Office - Cincinnati Children's Hospital Medica, 513-636-2799

    Recruiting

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106-5000

    Yousif (Joe) H. Matloub, 216-844-3345

    Recruiting

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

    Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente, 866-223-8100

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205-2696

    Laura T. Martin, 614-722-3582

    Recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

    Clinical Trials Office - Driscoll Children's Hospital, 361-694-5311

    Recruiting

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

    Dallas, Texas, 75390

    Clinical Trials Office - Simmons Comprehensive Cancer Center a, 866-460-4673; 214-648-7097

    Recruiting

  • Dayton Children's - Dayton

    Dayton, Ohio, 45404-1815

    Emmett H. Broxson, 937-641-3111

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

    Clinical Trials Office - City of Hope Comprehensive Cancer Cen, 800-826-4673, becomingapatient@coh.org

    Recruiting

  • CCOP - Duluth

    Duluth, Minnesota, 55805-1983

    Contact Person, 218-786-8364

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Clinical Trials Office - Duke Cancer Institute, 888-275-3853

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

    Clinical Trials Office - Inova Fairfax Hospital, 703-208-6650

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Clinical Trials Office - Hurley Medical Center, 810-762-8057

    Recruiting

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

    Clinical Trials Office - Cook's Children's Medical Center, 682-885-2103

    Recruiting

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

    Clinical Trials Office - Helen DeVos Children's Hospital, 616-391-3050

    Recruiting

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

    Clinical Trials Office - St. Vincent Hospital Regional Cancer, 920-433-8889

    Recruiting

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

    Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M, 252-744-2391

    Recruiting

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

    Clinical Trials Office - Greenville Hospital Cancer Center, 864-241-6251

    Recruiting

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

    Grosse Pointe Woods, Michigan, 48236

    Clincial Trials Office - Van Elslander Cancer Center at St. Jo, 313-343-3166

    Recruiting

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

    Clinical Trials Office - Hackensack University Medical Center, 201-996-2879

    Recruiting

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033-0850

    John F. Kuttesch, 717-531-6012

    Recruiting

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

    Clinical Trials Office - Cancer Research Center of Hawaii, 808-586-2979

    Recruiting

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

    Cancer Information Service, 800-237-1225

    Recruiting

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216-4505

    Gail C. Megason, 601-984-5220

    Recruiting

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

    Eric S. Sandler, 904-697-3793

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007-5381

    Jeffrey S. Lobel, 269-341-6350

    Recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    Maxine L. Hetherington, 816-234-3265

    Recruiting

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916

    Ray C. Pais, 865-541-8266

    Recruiting

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

    Clinical Trials Office - Breslin Cancer Center at Ingham Regio, 517-334-2765

    Recruiting

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89109-2306

    Jonathan Bernstein, 702-732-1493

    Recruiting

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Clinical Trial Office - Arkansas Cancer Research Center at Uni, 501-686-8274

    Recruiting

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

    Leo Mascarenhas, 323-361-2529

    Recruiting

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

    Robert M. Cooper, 323-783-5307

    Recruiting

  • Kosair Children's Hospital

    Louisville, Kentucky, 40232

    Clinical Trials Office - Kosair Children's Hospital, 502-629-5500, CancerResource@nortonhealthcare.org

    Recruiting

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

    Clinical Trials Office - Marshfield Clinic - Marshfield Center, 800-782-1581 ext. 94457

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

    University of Miami Sylvester Comprehensive Cancer Center Clin, 866-574-5124, Sylvester@emergingmed.com

    Recruiting

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

    Milwaukee, Wisconsin, 53226

    Michael E. Kelly, 414-456-4170

    Recruiting

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

    Clinical Trials Office - Children's Hospitals and Clinics of M, 612-813-5193

    Recruiting

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

    Clinical Trials Office - Masonic Cancer Center at University o, 612-624-2620

    Recruiting

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

    Clinical Trials Office - Children's Hospital of New Orleans, 504-894-5377

    Recruiting

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

    Clinical Trials Office - Herbert Irving Comprehensive Cancer C, 212-305-8615

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507-1971

    Eric J. Lowe, 757-668-7243

    Recruiting

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

    Rene Y. McNall-Knapp, 405-271-5311

    Recruiting

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

    Ramamoorthy Nagasubramanian, 407-650-7230

    Recruiting

  • Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 95798

    Neyssa M. Marina, 650-723-5535

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Jeffrey H. Schwartz, 850-505-4790

    Recruiting

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61603

    Pedro A. De Alarcon, 309-655-4242

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Elizabeth Fox, 267-425-3010

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

    Jessica Boklan, 602-546-0920

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15213

    Clinical Trials Office - Children's Hospital of Pittsburgh, 412-692-7056

    Recruiting

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

    Clinical Trials Office - Legacy Emanuel Children's Hospital, 503-413-2560

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Clinical Trials Office - All Mayo Clinic Locations, 507-538-7623

    Recruiting

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

    Rochester, New York, 14642

    Lisa R. Hackney, 585-275-2981

    Recruiting

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95661

    Vincent A. Kiley, 916-474-2326

    Recruiting

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

    Saint Paul, Minnesota, 55102-2392

    Contact Person, 612-220-6000

    Recruiting

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

    Phillip E. Barnette, 801-662-4700

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

    Anne-Marie R. Langevin, 210-567-7477

    Recruiting

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229-3993

    Jaime Estrada, 210-575-7268

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123-4282

    Clinical Trials Office - Rady Children's Hospital - San Diego, 858-966-5934

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

    Clinical Trials Office - UCSF Helen Diller Family Comprehensi, 877-827-3222

    Recruiting

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

    Julie R. Park, 206-987-2106

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Contact Person, 605-322-3000

    Recruiting

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99220-2555

    Judy L. Felgenhauer, 509-474-2777

    Recruiting

  • Simmons Cooper Cancer Institute

    Springfield, Illinois, 62794-9677

    Clinical Trials Office - Simmons Cooper Cancer Institute, 217-545-7929

    Recruiting

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

    Robert J. Hayashi, 314-454-2041

    Recruiting

  • All Children's Hospital

    St. Petersburg, Florida, 33701

    Gregory A. Hale, 727-767-4176

    Recruiting

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

    Clinical Trials Office - SUNY Upstate Medical University Hospi, 315-464-5476

    Recruiting

  • Mary Bridge Children's Hospital and Health Center - Tacoma

    Tacoma, Washington, 98405

    Robert G. Irwin, 253-403-3481

    Recruiting

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

    Tampa, Florida, 33607

    Clinical Trials Office - St. Joseph's Cancer Institute, 800-882-4123

    Recruiting

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

    Clinical Trials Office - Albert Einstein Cancer Center at Albe, 718-904-2730, aecc@aecom.yu.edu

    Recruiting

  • Toledo Hospital

    Toledo, Ohio, 43606

    Clinical Trials Office - Toledo Hospital, 419-824-1842

    Recruiting

  • Children's National Medical Center

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

    Clinical Trials Office - Children's National Medical Center, 202-884-2549

    Recruiting

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

    Narayana Gowda, 561-844-6363

    Recruiting

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803

    Clinical Trials Office - Alfred I. duPont Hospital for Childre, 302-651-5755

    Recruiting

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

    Clinical Trials Office - Tod Children's Hospital, 330-884-3955

    Recruiting

Other trials in United States

Canada9 sites, 9 recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Sunil Jayantilal' S. Desai, 780-248-5530

    Recruiting

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

    Margaret C. Yhap, 902-470-8778

    Recruiting

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

    Yvan Samson, 514-345-4931x2790

    Recruiting

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1V 4G2

    Bruno Michon, 418-656-4141X47191

    Recruiting

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

    Christopher Mpofu, 306-655-2744

    Recruiting

  • Janeway Children's Health and Rehabilitation Centre

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

    Lisa Anne B. Goodyear, 709-777-4303

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Sylvain Baruchel, 416-813-7795

    Recruiting

  • Children's and Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

    Caron Strahlendorf, 604-875-3576

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Rochelle A. Yanofsky, 204-787-4163

    Recruiting

Other trials in Canada

Australia4 sites, 4 recruiting

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

    Helen Irving, 617-3636-8671

    Recruiting

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

    Maria L. Kirby, 61881617411

    Recruiting

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

    Catherine H. Cole, 011-6189340-8238

    Recruiting

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

    Geoffrey B. McCowage, 61298452122

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Starship Children's Health

    Auckland, 1

    Lochie R. Teague, 649-307-4949x22423

    Recruiting

Other trials in New Zealand

Puerto Rico1 site, 1 recruiting

  • San Jorge Children's Hospital

    Santurce, 00912

    Luis A. Clavell, 787-728-1575

    Recruiting

Other trials in Puerto Rico

About this study

Official title: European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)

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.

Read the detailed description

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
Sarcoma
Keywords
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Medical subject headings
Sarcoma, Neuroectodermal Tumors, Primitive, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00020566
Study groupRoleWhat they receive
Group 1ExperimentalPatients 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.
Receives: Biological: dactinomycin; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: conventional surgery; Radiation: radiation therapy
Group 2, arm IExperimentalPatients 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.
Receives: Biological: dactinomycin; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: conventional surgery; Radiation: radiation therapy
Group 2, arm IIExperimentalPatients 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.
Receives: Biological: dactinomycin; Drug: busulfan; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: melphalan; Drug: vincristine sulfate; Procedure: autologous hematopoietic stem cell transplantation; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

  2. Overall survival

Secondary outcomes (2)

  1. Feasibility, toxicity, and response at 1 month following induction therapy

  2. Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00020566
Sponsor's protocol ID
CDR0000068608
Other IDs
EURO-EWING-INTERGROUP-EE99, EBMT-INTERGROUP-EE99, EORTC-62981, GPOH-AUSTRIA-INTERGROUP-EE99, GPOH-GERMANY-INTERGROUP-EE99, SFOP-INTERGROUP-EE99, SWS-SAKK-INTERGROUP-EE99, CCLG-INTERGROUP-EE99
Status last verified
Jun 2012
First submitted
11 Jul 2001
Last updated
24 Jun 2014
Results posted
No

Publications

  • 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.

    PubMed 20547982

  • 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.

    PubMed 20308673

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dactinomycin, busulfan and doxorubicin hydrochloride in people with Sarcoma, run by University of Leicester at 103 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Canada, Australia, New Zealand, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00020566, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.

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