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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) Southwest Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006734 |
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.
Condition | Intervention | Phase |
Sarcoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: brachytherapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Ifosfamide Cyclophosphamide Filgrastim Etoposide Vincristine sulfate Vincristine Etoposide phosphate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors |
Study Start Date: | May 2001 |
OBJECTIVES:
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):
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:
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.
Ages Eligible for Study: | up to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues
Paraspinal or bony skull tumors of extradural origin allowed
Askin's tumor of the chest wall allowed
No metastatic disease or distant node involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 239 Study Locations |
Children's Oncology Group |
National Cancer Institute (NCI) |
Southwest Oncology Group |
Study Chair: | Richard B. Womer, MD | Children's Hospital of Philadelphia |
Investigator: | Karen H. Albritton, MD | Dana-Farber Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068323, COG-AEWS0031, CCG-A7983, SWOG-COG-AEWS0031 |
First Received: | December 6, 2000 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006734 |
Health Authority: | United States: Federal Government |
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