Status:
UNKNOWN
Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Localized Extraskeletal Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor of Bone
Eligibility:
All Genders
Up to 50 years
Phase:
PHASE3
Brief Summary
This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not sprea...
Detailed Description
PRIMARY OBJECTIVES: l. Test the effect of the combination of vincristine (vincristine sulfate), cyclophosphamide, and topotecan (topotecan hydrochloride) (VTC) added to the standard 5-drug interval-c...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:
- For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease
- Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic
- Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic
- Tumors arising in the bony skull (extra-dural) are considered to be extracranial
- Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
- No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70mL/min/1.73 m\^2 or serum creatinine based on age/gender as follows:
- 1 month to \< 6 months: 0.4 mg/dL
- 6 months to \< 1 year: 0.5 mg/dL
- 1 to \< 2 years: 0.6 mg/dL
- 2 to \< 6 years: 0.8 mg/dL
- 6 to \< 10 years: 1 mg/dL
- 10 to \< 13 years: 1.2 mg/dL
- 13 to \< 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
- \>= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
- Total bilirubin \< 1.5 x upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age
- Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram
Exclusion
- Patients must have no evidence of metastatic disease; metastatic disease are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken
- Skeletal lesions in adjacent bones (trans-articular)
- Contralateral pleural effusion and contralateral pleural nodules
- Distant lymph node involvement
- Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
- Solitary nodule \> 0.5 cm or multiple nodules of \> 0.3 cm unless biopsied and negative for Ewing's
- Biopsies of solitary nodule =\< 0.5 cm or multiple nodules =\< 0.3 cm are not required but if performed and positive indicate metastatic disease
- Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
- Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
- Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
- Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
642 Patients enrolled
Trial Details
Trial ID
NCT01231906
Start Date
November 22 2010
Last Update
October 1 2025
Active Locations (243)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508