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Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006734
First Posted: January 27, 2003
Last Update Posted: May 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by (Responsible Party):
Children's Oncology Group
December 6, 2000
January 27, 2003
May 17, 2013
May 2001
August 2006   (Final data collection date for primary outcome measure)
Event-free survival [ 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 ]
Assessed using a two sided log rank test of 0.05.
Not Provided
Complete list of historical versions of study NCT00006734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor
Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor.

PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.

OBJECTIVES:

  • 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 courses.
    • 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 courses.

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 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma
  • Biological: filgrastim
    Given IV
    Other Names:
    • GRANULOCYTE COLONY-STIMULATING FACTOR
    • r-metHuG-CSF
    • G-CSF
    • Neupogen
    • NSC 614629
  • Drug: cyclophosphamide
    Given IV
    Other Names:
    • CTX
    • Cytoxan
    • NSC #026271
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • Adriamycin
    • NSC #123127
    • IND #7038
  • Drug: etoposide
    Given IV
    Other Names:
    • VP-16
    • VePesid
    • Etopophos
    • NSC #141540
  • Drug: ifosfamide
    Given IV
    Other Names:
    • Ifex
    • NSC #109724
  • Drug: vincristine sulfate
    Given IV
    Other Names:
    • Oncovin
    • NSC #067574
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: brachytherapy
  • Radiation: radiation therapy
  • Experimental: Regimen A
    Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.
    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: ifosfamide
    • Drug: vincristine sulfate
    • Procedure: adjuvant therapy
    • Procedure: conventional surgery
    • Procedure: neoadjuvant therapy
    • Radiation: brachytherapy
    • Radiation: radiation therapy
  • Experimental: Regimen B
    Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.
    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: ifosfamide
    • Drug: vincristine sulfate
    • Procedure: adjuvant therapy
    • Procedure: conventional surgery
    • Procedure: neoadjuvant therapy
    • Radiation: brachytherapy
    • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
587
Not Provided
August 2006   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 50 and under at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine normal for age
  • Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min

Cardiovascular:

  • Shortening fraction at least 28% by echocardiography OR
  • Ejection fraction at least 55% by radionuclide angiogram

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for skin cancer
  • No concurrent sargramostim (GM-CSF)
  • No concurrent pegfilgrastim

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Prior complete or partial excision of primary tumor allowed
Sexes Eligible for Study: All
up to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland,   United States
 
 
NCT00006734
AEWS0031
COG-AEWS0031 ( Other Identifier: Children's Oncology Group )
CDR0000068323 ( Other Identifier: Clinical Trials.gov )
A7983 ( Other Identifier: Children's Cancer Group )
Yes
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
Study Chair: Richard B. Womer, MD Children's Hospital of Philadelphia
Children's Oncology Group
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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