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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) Southwest Oncology Group |
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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 |
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 |
Phase III |
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):
Continuation therapy:
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:
Study Chair: | Richard B. Womer, MD | Children's Hospital of Philadelphia |
Investigator: | Karen H. Albritton, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000068323, COG-AEWS0031, CCG-A7983, SWOG-COG-AEWS0031 |
Study First Received: | December 6, 2000 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00006734 History of Changes |
Health Authority: | United States: Federal Government |
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Neuroectodermal Tumors, Primitive Immunologic Factors Cyclophosphamide Etoposide phosphate Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Sarcoma, Ewing's Neoplasms, Germ Cell and Embryonal Neuroepithelioma Osteogenic Sarcoma Ewing's Family of Tumors Alkylating Agents Etoposide Adjuvants, Immunologic |
Osteosarcoma Vincristine Antimitotic Agents Ewing's Sarcoma Immunosuppressive Agents Doxorubicin Neuroectodermal Tumors Malignant Mesenchymal Tumor Ifosfamide Tubulin Modulators Sarcoma Peripheral Neuroectodermal Tumor Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators Osteosarcoma |
Vincristine Antimitotic Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Ifosfamide Neoplasms Neoplasms, Bone Tissue Tubulin Modulators Myeloablative Agonists Sarcoma Neoplasms, Connective Tissue Antineoplastic Agents, Alkylating Antirheumatic Agents |