Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Active | Under 50 | NCI, Other | CDR0000068608 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, COG-AEWS0331, EU-20213, AEWS0331, NCT00020566 |
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. 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.
Further Study Information
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.
Eligibility 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
Trial Lead Organizations/Sponsors
University Hospitals of Leicester NHS Trust
National Cancer InstituteChildren's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
European Organization for Research and Treatment of Cancer
Gesellschaft fuer Paediatrische Onkologie und Haematologie - Germany
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
Swiss Group for Clinical Cancer Research
EBMT Solid Tumors Working Party
Children's Oncology Group
| Alan W. Craft | ![]() | Study Chair |
| Ian J. Lewis | ![]() | Study Chair |
| Odile Oberlin | ![]() | Study Chair |
| Ian Robert Judson | ![]() |
| Heribert F. Juergens | ![]() | Study Chair |
| Helmut Gadner | ![]() | Study Chair |
| G. Ulrich Exner | ![]() | Study Chair |
| Ruth Ladenstein | ![]() | Study Chair |
| Douglas Hawkins | ![]() | Study Chair |
Trial Sites
| U.S.A. | |||
| Alabama | |||
| Birmingham | |||
| Children's Hospital of Alabama at University of Alabama at Birmingham | |||
| Alyssa T Reddy | Ph: 205-934-0309 | ||
| UAB Comprehensive Cancer Center | |||
| Alyssa T Reddy | Ph: 205-934-0309 | ||
| Arizona | |||
| Phoenix | |||
| Phoenix Children's Hospital | |||
| Jessica Boklan | Ph: 602-546-0920 | ||
| Arkansas | |||
| Little Rock | |||
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |||
| David L Becton | Ph: 501-364-7373 | ||
| California | |||
| Downey | |||
| Southern California Permanente Medical Group | |||
| Robert M Cooper | Ph: 626-564-3455 | ||
| Duarte | |||
| City of Hope Comprehensive Cancer Center | |||
| Anna B Pawlowska | Ph: 800-826-4673 | ||
| Email: becomingapatient@coh.org | |||
| Los Angeles | |||
| Childrens Hospital Los Angeles | |||
| Leo Mascarenhas | Ph: 323-361-4110 | ||
| Oakland | |||
| Kaiser Permanente-Oakland | |||
| Vincent A Kiley | Ph: 626-564-3455 | ||
| Palo Alto | |||
| Lucile Packard Children's Hospital at Stanford University Medical Center | |||
| Neyssa M Marina | Ph: 650-498-7061 | ||
| Email: clinicaltrials@med.stanford.edu | |||
| San Diego | |||
| Rady Children's Hospital - San Diego | |||
| William D Roberts | Ph: 858-966-5934 | ||
| San Francisco | |||
| UCSF Helen Diller Family Comprehensive Cancer Center | |||
| Robert E Goldsby | Ph: 877-827-3222 | ||
| Colorado | |||
| Aurora | |||
| Children's Hospital Colorado Center for Cancer and Blood Disorders | |||
| Brian S Greffe | Ph: 720-777-6672 | ||
| Delaware | |||
| Wilmington | |||
| Alfred I. duPont Hospital for Children | |||
| Christopher N Frantz | Ph: 302-651-5755 | ||
| District of Columbia | |||
| Washington | |||
| Children's National Medical Center | |||
| Jeffrey S Dome | Ph: 202-884-2549 | ||
| Florida | |||
| Jacksonville | |||
| Nemours Children's Clinic | |||
| Eric S Sandler | Ph: 904-697-3529 | ||
| Miami | |||
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |||
| Julio C Barredo | Ph: 866-574-5124 | ||
| Email: Sylvester@emergingmed.com | |||
| Orlando | |||
| Nemours Children's Clinic - Orlando | |||
| Ramamoorthy Nagasubramanian | Ph: 407-650-7150 | ||
| Pensacola | |||
| Nemours Children's Clinic - Pensacola | |||
| Jeffrey H Schwartz | Ph: 904-697-3529 | ||
| Saint Petersburg | |||
| All Children's Hospital | |||
| Gregory A Hale | Ph: 727-767-2423 | ||
| Email: HamblinF@allkids.org | |||
| Tampa | |||
| St. Joseph's Children's Hospital of Tampa | |||
| Hardeo K Panchoosingh | Ph: 800-882-4123 | ||
| West Palm Beach | |||
| Kaplan Cancer Center at St. Mary's Medical Center | |||
| Narayana Gowda | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Georgia | |||
| Atlanta | |||
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |||
| Howard M Katzenstein | Ph: 888-785-1112 | ||
| Hawaii | |||
| Honolulu | |||
| Cancer Research Center of Hawaii | |||
| Robert W Wilkinson | Ph: 808-983-6090 | ||
| Idaho | |||
| Boise | |||
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | |||
| Eugenia Chang | Ph: 800-845-4624 | ||
| Illinois | |||
| Chicago | |||
| University of Chicago Cancer Research Center | |||
| Susan L Cohn | Ph: 773-834-7424 | ||
| University of Illinois Cancer Center | |||
| Mary L Schmidt | Ph: 312-355-3046 | ||
| Peoria | |||
| Saint Jude Midwest Affiliate | |||
| Pedro A De Alarcon | Ph: 309-655-3258 | ||
| Springfield | |||
| Simmons Cooper Cancer Institute | |||
| Gregory P Brandt | Ph: 217-545-7929 | ||
| Iowa | |||
| Iowa City | |||
| Holden Comprehensive Cancer Center at University of Iowa | |||
| Raymond Tannous | Ph: 800-237-1225 | ||
| Kentucky | |||
| Lexington | |||
| University of Kentucky Chandler Medical Center | |||
| Martha F Greenwood | Ph: 859-257-3379 | ||
| Louisville | |||
| Kosair Children's Hospital | |||
| Salvatore J Bertolone | Ph: 866-530-5516 | ||
| Massachusetts | |||
| Boston | |||
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |||
| Carlos Rodriguez-Galindo | Ph: 866-790-4500 | ||
| Michigan | |||
| Detroit | |||
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |||
| Hadi Sawaf | Ph: 313-343-3166 | ||
| Flint | |||
| Hurley Medical Center | |||
| Susumu Inoue | Ph: 888-606-6556 | ||
| Grand Rapids | |||
| Helen DeVos Children's Hospital at Spectrum Health | |||
| David S Dickens | Ph: 616-267-1925 | ||
| Kalamazoo | |||
| Bronson Methodist Hospital | |||
| Jeffrey S Lobel | Ph: 800-227-2345 | ||
| Western Michigan University School of Medicine Clinics | |||
| Jeffrey S Lobel | Ph: 800-227-2345 | ||
| Lansing | |||
| Breslin Cancer Center at Ingham Regional Medical Center | |||
| Renuka Gera | Ph: 517-334-2765 | ||
| Minnesota | |||
| Minneapolis | |||
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |||
| Bruce C Bostrom | Ph: 612-813-5193 | ||
| Masonic Cancer Center at University of Minnesota | |||
| Joseph P Neglia | Ph: 612-624-2620 | ||
| Rochester | |||
| Mayo Clinic Cancer Center | |||
| Carola A. S. Arndt | Ph: 507-538-7623 | ||
| Mississippi | |||
| Jackson | |||
| University of Mississippi Cancer Clinic | |||
| Gail C Megason | Ph: 601-815-6700 | ||
| Missouri | |||
| Kansas City | |||
| Children's Mercy Hospital | |||
| Maxine L Hetherington | Ph: 816-234-3265 | ||
| Saint Louis | |||
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |||
| Shalini Shenoy | Ph: 800-600-3606 | ||
| Email: info@siteman.wustl.edu | |||
| Nevada | |||
| Las Vegas | |||
| CCOP - Nevada Cancer Research Foundation | |||
| Jonathan Bernstein | Ph: 702-384-0013 | ||
| New Jersey | |||
| Hackensack | |||
| Hackensack University Medical Center Cancer Center | |||
| Burton E Appel | Ph: 201-996-2879 | ||
| New York | |||
| Bronx | |||
| Montefiore Medical Center | |||
| Rosanna J Ricafort | Ph: 718-904-2730 | ||
| Email: aecc@aecom.yu.edu | |||
| New York | |||
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |||
| Alice Lee | Ph: 212-305-8615 | ||
| Rochester | |||
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |||
| Lisa R Hackney | Ph: 585-275-5830 | ||
| Syracuse | |||
| SUNY Upstate Medical University Hospital | |||
| Irene Cherrick | Ph: 315-464-5476 | ||
| Valhalla | |||
| New York Medical College | |||
| Mehmet F Ozkaynak | Ph: 914-594-3794 | ||
| North Carolina | |||
| Charlotte | |||
| Presbyterian Cancer Center at Presbyterian Hospital | |||
| Paulette C Bryant | Ph: 704-384-5369 | ||
| Durham | |||
| Duke Cancer Institute | |||
| Susan G Kreissman | Ph: 888-275-3853 | ||
| Greenville | |||
| Leo W. Jenkins Cancer Center at ECU Medical School | |||
| Mauro Grossi | Ph: 252-744-2161 | ||
| Ohio | |||
| Cincinnati | |||
| Cincinnati Children's Hospital Medical Center | |||
| John P Perentesis | Ph: 513-636-2799 | ||
| Cleveland | |||
| Seidman Cancer Center at University Hospitals/Case Medical Center | |||
| Yousif (Joe) H Matloub | Ph: 216-844-5437 | ||
| Columbus | |||
| Nationwide Children's Hospital | |||
| Laura T Martin | Ph: 614-722-2708 | ||
| Dayton | |||
| Dayton Children's - Dayton | |||
| Emmett H Broxson | Ph: 800-228-4055 | ||
| Toledo | |||
| Toledo Hospital | |||
| Dagmar T Stein | Ph: 419-824-1842 | ||
| Oklahoma | |||
| Oklahoma City | |||
| Oklahoma University Cancer Institute | |||
| Rene Y McNall-Knapp | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Oregon | |||
| Portland | |||
| Legacy Emanuel Children's Hospital | |||
| Janice F Olson | Ph: 503-413-2560 | ||
| Legacy Emanuel Hospital and Health Center and Children's Hospital | |||
| Janice F Olson | Ph: 503-413-2560 | ||
| Pennsylvania | |||
| Bethlehem | |||
| Lehigh Valley Hospital - Muhlenberg | |||
| Philip M Monteleone | Ph: 484-884-2201 | ||
| Hershey | |||
| Penn State Children's Hospital | |||
| Lisa M McGregor | Ph: 717-531-6012 | ||
| Pittsburgh | |||
| Children's Hospital of Pittsburgh of UPMC | |||
| Peter H Shaw | Ph: 412-692-5573 | ||
| PR | |||
| Santurce | |||
| San Jorge Children's Hospital | |||
| Luis A Clavell | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| South Carolina | |||
| Charleston | |||
| Hollings Cancer Center at Medical University of South Carolina | |||
| Jacqueline M Kraveka | Ph: 843-792-9321 | ||
| Greenville | |||
| BI-LO Charities Children's Cancer Center | |||
| Nichole L Bryant | Ph: 864-241-6251 | ||
| Cancer Centers of the Carolinas - Faris Road | |||
| Nichole L Bryant | Ph: 864-241-6251 | ||
| Texas | |||
| Amarillo | |||
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |||
| Osvaldo Regueira | Ph: 806-354-5411 | ||
| Corpus Christi | |||
| Driscoll Children's Hospital | |||
| M. C Johnson | Ph: 361-694-5311 | ||
| Dallas | |||
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||
| Naomi J Winick | Ph: 214-648-7097 | ||
| Fort Worth | |||
| Cook Children's Medical Center - Fort Worth | |||
| Mary Meaghan P Granger | Ph: 682-885-2103 | ||
| San Antonio | |||
| Methodist Children's Hospital of South Texas | |||
| Jaime Estrada | Ph: 210-575-7000 | ||
| University of Texas Health Science Center at San Antonio | |||
| Paul J Thomas | Ph: 210-567-0653 | ||
| Email: che@uthscsa.edu | |||
| Temple | |||
| Scott and White Cancer Institute | |||
| Guy H Grayson | Ph: 254-724-5407 | ||
| Utah | |||
| Salt Lake City | |||
| Primary Children's Medical Center | |||
| Phillip E Barnette | Ph: 801-585-5270 | ||
| Virginia | |||
| Charlottesville | |||
| University of Virginia Cancer Center | |||
| Kimberly P Dunsmore | Ph: 434-243-6143 | ||
| Falls Church | |||
| Inova Fairfax Hospital | |||
| Marshall A Schorin | Ph: 703-208-6650 | ||
| Norfolk | |||
| Children's Hospital of The King's Daughters | |||
| Eric J Lowe | Ph: 757-668-7243 | ||
| Washington | |||
| Seattle | |||
| Children's Hospital and Regional Medical Center - Seattle | |||
| Douglas S Hawkins | Ph: 866-987-2000 | ||
| Spokane | |||
| Providence Cancer Center at Sacred Heart Medical Center | |||
| Douglas S Hawkins | Ph: 866-987-2000 | ||
| Tacoma | |||
| Mary Bridge Children's Hospital and Health Center - Tacoma | |||
| Douglas S Hawkins | Ph: 866-987-2000 | ||
| West Virginia | |||
| Charleston | |||
| West Virginia University Medical School - Charleston | |||
| Allen R Chauvenet | Ph: 304-388-9944 | ||
| Wisconsin | |||
| Green Bay | |||
| St. Vincent Hospital Regional Cancer Center | |||
| John R Hill | Ph: 920-433-8889 | ||
| Marshfield | |||
| Marshfield Clinic - Marshfield Center | |||
| Michael J McManus | Ph: 715-389-4457 | ||
| Milwaukee | |||
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |||
| Michael E Kelly | Ph: 414-805-4380 | ||
| Australia | |||
| New South Wales | |||
| Sydney | |||
| Children's Hospital at Westmead | |||
| Geoffrey B McCowage | Ph: 61-2-9845 1400 | ||
| Queensland | |||
| Herston | |||
| Royal Brisbane and Women's Hospital | |||
| Helen Irving | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Royal Children's Hospital | |||
| Helen Irving | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| South Australia | |||
| North Adelaide | |||
| Women's and Children's Hospital | |||
| Maria L Kirby | Ph: (08) 8161 7327 | ||
| Email: cywhs.oncsec@health.sa.gov.au | |||
| Western Australia | |||
| Perth | |||
| Princess Margaret Hospital for Children | |||
| Catherine H Cole | Ph: (08) 9340 8330 | ||
| Email: admin@childcancerresearch.com.au | |||
| Canada | |||
| Alberta | |||
| Edmonton | |||
| University of Alberta Hospital | |||
| Sunil Jayantilal` S Desai | Ph: 780-407-6615 | ||
| Email: val.taylor@albertahealthservices.ca | |||
| British Columbia | |||
| Vancouver | |||
| Children's and Women's Hospital of British Columbia | |||
| Caron Strahlendorf | Ph: 604-875-2345ext6477 | ||
| Manitoba | |||
| Winnipeg | |||
| CancerCare Manitoba | |||
| Rochelle A Yanofsky | Ph: 866-561-1026 | ||
| Email: CIO_Web@cancercare.mb.ca | |||
| Newfoundland and Labrador | |||
| Saint John's | |||
| Janeway Children's Health and Rehabilitation Centre | |||
| John P Hand | Ph: 866-722-1126 | ||
| Nova Scotia | |||
| Halifax | |||
| IWK Health Centre | |||
| Margaret C Yhap | Ph: 902-470-8394 | ||
| Ontario | |||
| Toronto | |||
| Hospital for Sick Children | |||
| Sylvain Baruchel | Ph: 416-813-7654ext2027 | ||
| Email: jason.mcguire@sickkids.ca | |||
| Quebec | |||
| Montreal | |||
| Hopital Sainte Justine | |||
| Yvan Samson | Ph: 514-345-4931 | ||
| Montreal Children's Hospital at McGill University Health Center | |||
| Sharon B Abish | Ph: 514-412-4445 | ||
| Email: info@thechildren.com | |||
| Ste-Foy | |||
| Centre de Recherche du Centre Hospitalier de l'Universite Laval | |||
| Bruno Michon | Ph: 418-525-4444 | ||
| Saskatchewan | |||
| Saskatoon | |||
| Saskatoon Cancer Centre at the University of Saskatchewan | |||
| Christopher Mpofu | Ph: 306-655-2914 | ||
| New Zealand | |||
| Auckland | |||
| Grafton | |||
| Starship Children's Health | |||
| Lochie R Teague | Ph: 0800 728 436 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00020566
Information obtained from ClinicalTrials.gov on November 20, 2012
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