Know Cancer

forgot password

Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors

Phase 3
50 Years
Not Enrolling

Thank you

Trial Information

Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors


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

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

- Induction therapy (weeks 1-12):

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

- Arm II: Patients receive alternating courses of chemotherapy consisting of
vincristine, doxorubicin, and cyclophosphamide as in arm I for courses 1, 3, and 5
and ifosfamide and etoposide as in arm I for courses 2, 4, and 6. Patients also
receive G-CSF as in arm I. Treatment continues every 2 weeks for 6 courses.

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

- Continuation therapy:

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

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

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

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

Inclusion Criteria


- Histologically confirmed localized Ewing's sarcoma or peripheral primitive
neuroectodermal tumor (PNET) of the bone or soft tissues

- Diagnostic biopsy of primary tumor within 30 days of study

- Paraspinal or bony skull tumors of extradural origin allowed

- No intradural soft tissue tumors

- Askin's tumor of the chest wall allowed

- Chest wall tumors with ipsilateral pleural effusions or ipsilateral
pleural-based secondary tumor nodules allowed

- No contralateral pleural effusions

- No metastatic disease or distant node involvement

- One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1
nodule greater than 0.5 cm in diameter are considered pulmonary metastasis

- Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed
unless biopsy positive for tumor

- Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's
sarcoma or peripheral PNET

- No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma

- No esthesioneuroblastoma

- Clinically or pathologically involved regional lymph nodes allowed

- No CNS involvement



- 50 and under at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Bilirubin no greater than 1.5 mg/dL


- Creatinine normal for age

- Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min


- Shortening fraction at least 28% by echocardiography OR

- Ejection fraction at least 55% by radionuclide angiogram


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy except skin cancer diagnosed at least 5 years ago and
currently in remission


Biologic therapy:

- No prior immunotherapy for skin cancer

- No concurrent sargramostim (GM-CSF)

- No concurrent pegfilgrastim


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy


- Prior complete or partial excision of primary tumor allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Description:

Assessed using a two sided log rank test of 0.05.

Outcome Time Frame:

Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years

Safety Issue:


Principal Investigator

Richard B. Womer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

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



Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
Deaconess Medical CenterSpokane, Washington  99210-0248
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
St. Barnabas Medical CenterLivingston, New Jersey  07039
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Joe DiMaggio Children's Hospital at MemorialHollywood, Florida  33021
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Sacred Heart Children's HospitalPensacola, Florida  32504
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Floating Hospital for ChildrenBoston, Massachusetts  02111
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
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
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Santa Barbara Cottage HospitalSanta Barbara, California  93102
Medical Center of Central GeorgiaMacon, Georgia  31201
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
St. Louis Children's HospitalSaint Louis, Missouri  63110
Children's Hospital of OmahaOmaha, Nebraska  68114
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Toledo Children's HospitalToledo, Ohio  43601
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Vincent Hospitals and Health Care CentersIndianapolis, Indiana  46260
SUNY Downstate Medical CenterBrooklyn, New York  11203
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Simmons Cancer Center at University of Texas Southwestern Medical Center at DallasDallas, Texas  75390
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Blank Children's HospitalDes Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite CampusAtlanta, Georgia  30342
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Carilion Medical Center for Children at Roanoke Community HospitalRoanoke, Virginia  24014
University of South Alabama Cancer Research InstituteMobile, Alabama  36604
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Jackson Memorial HospitalMiami, Florida  33136
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
University of Illinois Medical CenterChicago, Illinois  60612
Riley Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Valerie Fund Children's Center at Atlantic HealthSummit, New Jersey  07901
Comprehensive Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Dakota Cancer Institute at Innovis Health - Dakota ClinicFargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science UniversityPortland, Oregon  97239-3098
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
Methodist Cancer Center at Methodist Specialty and Transplant HospitalSan Antonio, Texas  78229-3902
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Cabell Huntington HospitalHuntington, West Virginia  25701
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California  94535
Children's Hospital Cancer CenterDenver, Colorado  80218
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
Pediatric Specialty Clinic at Eastern Maine Medical CenterBangor, Maine  04401
Walter Reed Army Medical CenterSilver Spring, Maryland  20910
DeVos Children's HospitalGrand Rapids, Michigan  49503
Children's Hospitals and Clinics - Minneapolis/St. PaulMinneapolis, Minnesota  55404
Children's Hospital at Albany Medical CenterAlbany, New York  12208
Leo W. Jenkins Cancer Center at Pitt County Memorial HospitalGreenville, North Carolina  27858-4354
Columbus Children's HospitalColumbus, Ohio  43205-2696
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Cancer Care Center at Skagit Valley HospitalMt. Vernon, Washington  98273
Medical College of Ohio Cancer InstituteMadison, Wisconsin  53792-6164