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


Phase 3
N/A
49 Years
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Alan W. Craft, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Authority:

Unspecified

Study ID:

CDR0000068608

NCT ID:

NCT00020566

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
CCOP - DuluthDuluth, Minnesota  55805
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Toledo HospitalToledo, Ohio  43606
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Childrens Hospital Los AngelesLos Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Children's Hospitals and Clinics of Minnesota - St. PaulSt. Paul, Minnesota  55102-2392
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Dayton Children's - DaytonDayton, Ohio  45404-1815
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
University of Virginia Cancer CenterCharlottesville, Virginia  22908
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
Duke Cancer InstituteDurham, North Carolina  27710
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Children's Hospital Colorado Center for Cancer and Blood DisordersAurora, Colorado  80045
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503