|Phase III||Treatment||Completed||50 and under at diagnosis||NCI, Other||AEWS0031|
COG-AEWS0031, CDR0000068323, A7983, CCG-A7983, SWOG-COG-AEWS0031, 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.
Further Study Information
- 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.
- 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
- Not specified
- 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
PRIOR CONCURRENT THERAPY:
- No prior immunotherapy for skin cancer
- No concurrent sargramostim (GM-CSF)
- No concurrent pegfilgrastim
- No prior chemotherapy
- Not specified
- No prior radiotherapy
- Prior complete or partial excision of primary tumor allowed
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
Southwest Oncology Group
|Richard Berry Womer||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006734
ClinicalTrials.gov processed this data on January 15, 2014
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