Status:
WITHDRAWN
Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized Ewing's Sarcoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 50 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, and topotecan, work in different ways to stop the growth of tumor cells, either by kil...
Detailed Description
OBJECTIVES: Primary * Compare the event-free and overall survival of patients with newly diagnosed localized Ewing's sarcoma treated with doxorubicin hydrochloride, cyclophosphamide, vincristine, et...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically and cytologically confirmed extracranial Ewing's sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue
- Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural-based secondary tumor nodules allowed
- Contralateral pleural effusions or pleural nodules are not eligible
- Tumor arising in the bony skull (extradural) are eligible
- Tumors arising in the intradural soft tissue are not eligible
- Newly diagnosed disease
- Only have had a biopsy of the primary tumor without an attempt at complete or partial resection
- Prior attempted or accomplished unplanned excision allowed provided adequate imaging was obtained prior to surgery AND resection considered incomplete and further local control required
- No evidence of metastatic disease, defined as lesions discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor
- No evidence of metastatic lung disease by CT scan
- One pulmonary nodule \> 1 cm in diameter OR \> 1 nodule \> 0.5 cm in diameter are considered evidence of pulmonary metastasis
- Solitary nodules 0.5-1.0 cm or multiple nodules 0.3-0.5 cm must be confirmed negative by biopsy
- Solitary nodules \< 0.5 cm or multiple nodules \< 0.3 cm not considered clear evidence of lung disease
- No distant nodule disease
- No esthesioneuroblastoma
- PATIENT CHARACTERISTICS:
- Performance status (PS) 0-2 (Karnofsky PS 50-100% for patients ≥ 16 years of age or Lansky PS 50-100% for patients \< 16 years of age)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT \< 2.5 times ULN
- Shortening fraction ≥ 27% by EKG
- Ejection fraction ≥ 50% by radionuclide angiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy
- No prior chemotherapy
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00334867
Start Date
December 1 2005
Last Update
June 28 2013
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