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

Phase 3
50 Years
Not Enrolling

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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



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Mayo Clinic Cancer Center Rochester, Minnesota  55905
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University of Mississippi Medical Center Jackson, Mississippi  39216-4505
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Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
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St. Vincent Hospital Green Bay, Wisconsin  54307-3508
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Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
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Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
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Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
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Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
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All Children's Hospital St. Petersburg, Florida  33701
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Children's Hospital of New Orleans New Orleans, Louisiana  70118
Maine Children's Cancer Program Scarborough, Maine  04074-9308
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Floating Hospital for Children Boston, Massachusetts  02111
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Schneider Children's Hospital New Hyde Park, New York  11042
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UCSF Comprehensive Cancer Center San Francisco, California  94115
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Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
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Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
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St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
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Penn State Children's Hospital Hershey, Pennsylvania  17033-0850
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Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Jackson Memorial Hospital Miami, Florida  33136
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
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Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
Methodist Cancer Center at Methodist Specialty and Transplant Hospital San Antonio, Texas  78229-3902
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
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DeVos Children's Hospital Grand Rapids, Michigan  49503
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Children's Hospital at Albany Medical Center Albany, New York  12208
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Medical College of Ohio Cancer Institute Madison, Wisconsin  53792-6164