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Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor
Not Recruiting
Trial ID: NCT00006734
Purpose
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.
Official Title
Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors
Eligibility
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
Intervention(s):
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
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto,
California
94304