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Trial record 1 of 1 for:
AEWS1031
Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01231906
First received: October 29, 2010
Last updated: February 8, 2017
Last verified: February 2017
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Purpose
This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
| Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) Childhood Supratentorial Primitive Neuroectodermal Tumor Ewing Sarcoma of Bone Extraosseous Ewing Sarcoma Extraosseous Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Peripheral Primitive Neuroectodermal Tumor of the Kidney Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Drug: vincristine sulfate Drug: doxorubicin hydrochloride Drug: cyclophosphamide Drug: ifosfamide Drug: etoposide Drug: topotecan hydrochloride Other: laboratory biomarker analysis | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
Ewing sarcoma
MedlinePlus related topics:
Soft Tissue Sarcoma
Drug Information available for:
Topotecan hydrochloride
Genetic and Rare Diseases Information Center resources:
Soft Tissue Sarcoma
Ewing Sarcoma
Ewing's Family of Tumors
Neuroepithelioma
Supratentorial Primitive Neuroectodermal Tumor
Supratentorial Primitive Neuroectodermal Tumors, Childhood
Osteosarcoma
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- EFS [ Time Frame: Time from study enrollment to disease progression, appearance of disease at sites considered previously uninvolved, diagnosis of a second malignant neoplasm, death or last patient contact, assessed up to 5 years ]
- Overall survival [ Time Frame: Time from study enrollment to death or last patient contact, assessed up to 5 years ]
Secondary Outcome Measures:
- Relative risk for death [ Time Frame: Up to 5 years ]Estimated using the stratified partial likelihood for the relative risk regression model accounting for the factors used to stratify randomization at the time full information is obtained for the EFS comparison. Methods for censored survival data, including but not limited to log-rank comparisons and proportional hazards regression modeling will be used to assess prognostic significance.
- Histological response, in terms of event free survival after local control in patients who received local control therapy [ Time Frame: Up to 5 years ]Methods for censored survival data, including but not limited to log-rank comparisons and proportional hazards regression modeling will be used.
- Positron emission tomography (PET)-determined response, in terms of event free survival after local control [ Time Frame: Up to week 13 ]Methods for censored survival data, including but not limited to log-rank comparisons and proportional hazards regression modeling will be used.
- Probabilities of identifying tumors of at least 200 ml [ Time Frame: Up to 5 years ]A two sided log-rank test of size 0.05 as a function of the percent of patients for whom measurements can be obtained will be used.
- Extent of tumor necrosis according to the necrosis grading criteria in patients who have surgical resection of tumor [ Time Frame: Week 13 ]The probabilities of identifying patients with 'standard' necrosis grading as associated with increased risk using a two sided log-rank test of size 0.05 as a function of the percent of patients with 'standard' necrosis grading and its associated relative risk will be used.
- Radiological response of soft tissue component of mass by PET [ Time Frame: Up to week 13 ]The probabilities of identifying patients with complete response (CR) as associated with decreased risk for EFS-event when compared with patients with less-than-CR using a two sided log-rank test of size 0.05 as a function of the percent of patients with standard response and its associated relative risk will be used.
- Differences associated with local control modality on risk for EFS event, according to surgery only v. radiation therapy only v. surgery and radiation therapy [ Time Frame: Up to week 13 ]Stratified according to primary site of tumor as pelvis v. bone but not pelvis v. extra-osseous site. An omnibus log-rank test of size 0.05 will be used to assess whether there are differences associated with local control modality.
- Number and proportion of patients who experience any grade 2 or higher musculoskeletal event (ME), or surgery required to treat a complication of local therapy [ Time Frame: Up to 3 months post-local control therapy ]Will be based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The proportion of patients who experience any ME will be compared across the three regimens using an exact test of proportions of size 0.05.
- Proportion of patients who have tumor present at the margin of resection on risk for EFS event in patients undergoing surgery [ Time Frame: Week 13 ]
| Estimated Enrollment: | 693 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2019 |
| Estimated Primary Completion Date: | September 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (combination chemotherapy)
INDUCTION THERAPY: Patients receive vincristine sulfate (IV) on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. |
Drug: vincristine sulfate
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Experimental: Arm II (combination chemotherapy, topotecan hydrochloride)
INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1 and 9, and on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm I; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. |
Drug: vincristine sulfate
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: topotecan hydrochloride
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231906
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01231906
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Locations
| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| University of South Alabama | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Phoenix Childrens Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202-3591 | |
| United States, California | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Miller Children's Hospital | |
| Long Beach, California, United States, 90806 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States, 90095 | |
| Mattel Children's Hospital UCLA | |
| Los Angeles, California, United States, 90095 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93636-8762 | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Kaiser Permanente-Oakland | |
| Oakland, California, United States, 94611 | |
| Childrens Hospital of Orange County | |
| Orange, California, United States, 92868-3874 | |
| University of California Medical Center At Irvine-Orange Campus | |
| Orange, California, United States, 92868 | |
| Lucile Packard Children's Hospital Stanford University | |
| Palo Alto, California, United States, 94304 | |
| UC Davis Comprehensive Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123 | |
| University of California San Francisco Medical Center-Parnassus | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Children's Hospital Colorado | |
| Aurora, Colorado, United States, 80045 | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale University | |
| New Haven, Connecticut, United States, 06520-8032 | |
| United States, Delaware | |
| Alfred I duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| Lombardi Comprehensive Cancer Center at Georgetown University | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Broward Health Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| The Children's Hospital of Southwest Florida | |
| Fort Myers, Florida, United States, 33908 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Nemours Children's Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32207-8426 | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | |
| Miami, Florida, United States, 33136 | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33176 | |
| Florida Hospital | |
| Orlando, Florida, United States, 32803 | |
| M D Anderson Cancer Center- Orlando | |
| Orlando, Florida, United States, 32806 | |
| Nemours Children's Hospital | |
| Orlando, Florida, United States, 32827 | |
| Nemours Children's Clinic - Pensacola | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| Saint Petersburg, Florida, United States, 33701 | |
| Saint Joseph Children's Hospital of Tampa | |
| Tampa, Florida, United States, 33607 | |
| Saint Mary's Hospital | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Children's Healthcare of Atlanta - Egleston | |
| Atlanta, Georgia, United States, 30322 | |
| Georgia Regents University | |
| Augusta, Georgia, United States, 30912 | |
| Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403 | |
| United States, Hawaii | |
| University of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859 | |
| United States, Idaho | |
| Saint Luke's Mountain States Tumor Institute | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Lurie Children's Hospital-Chicago | |
| Chicago, Illinois, United States, 60614 | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Advocate Lutheran General Hospital | |
| Park Ridge, Illinois, United States, 60068 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61602 | |
| Saint John's Hospital | |
| Springfield, Illinois, United States, 62702 | |
| Southern Illinois University | |
| Springfield, Illinois, United States, 62702 | |
| Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| Saint Vincent Hospital and Health Services | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Raymond Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| Siouxland Hematology Oncology Associates | |
| Sioux City, Iowa, United States, 51101 | |
| Mercy Medical Center-Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Saint Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Children's Hospital-Main Campus | |
| New Orleans, Louisiana, United States, 70118 | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201-1595 | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-8936 | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889-5600 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| C S Mott Children's Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
| Wayne State University | |
| Detroit, Michigan, United States, 48202 | |
| Saint John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48502 | |
| Helen DeVos Children's Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Michigan State University - Breslin Cancer Center | |
| Lansing, Michigan, United States, 48910 | |
| Beaumont Children's Hospital-Royal Oak | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| University of Minnesota Medical Center-Fairview | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Columbia Regional | |
| Columbia, Missouri, United States, 65201 | |
| The Childrens Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Saint John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Children's Hospital and Medical Center of Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Nevada Cancer Research Foundation CCOP | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| UMDNJ - Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Saint Joseph's Regional Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07902 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467-2490 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| The Steven and Alexandra Cohen Children's Medical Center of New York | |
| New Hyde Park, New York, United States, 11040 | |
| New York University Langone Medical Center | |
| New York, New York, United States, 10016 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794 | |
| State University of New York Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Ny Cancer% | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Mission Hospitals | |
| Asheville, North Carolina, United States, 28801 | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Sanford Medical Center-Fargo | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Rainbow Babies and Childrens Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| The Children's Medical Center of Dayton | |
| Dayton, Ohio, United States, 45404 | |
| The Toledo Hospital/Toledo Children's Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Mercy Children's Hospital | |
| Toledo, Ohio, United States, 43608 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Natalie W Bryant Cancer Center | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Legacy Emanuel Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| Legacy Emanuel Hospital and Health Center | |
| Portland, Oregon, United States, 97227 | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Penn State Hershey Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Saint Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134 | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Palmetto Health Richland | |
| Columbia, South Carolina, United States, 29203 | |
| BI-LO Charities Children's Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Greenville Cancer Treatment Center | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Sanford USD Medical Center - Sioux Falls | |
| Sioux Falls, South Dakota, United States, 57117-5134 | |
| United States, Tennessee | |
| T C Thompson Children's Hospital | |
| Chattanooga, Tennessee, United States, 37403 | |
| East Tennessee Childrens Hospital | |
| Knoxville, Tennessee, United States, 37916 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Dell Children's Medical Center of Central Texas | |
| Austin, Texas, United States, 78723 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042 | |
| Childrens Hospital-King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Providence Sacred Heart Medical Center and Children's Hospital | |
| Spokane, Washington, United States, 99204 | |
| Mary Bridge Children's Hospital and Health Center | |
| Tacoma, Washington, United States, 98405 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| United States, West Virginia | |
| West Virginia University Charleston | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Froedtert and the Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
| Sydney Children's Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| The Children's Hospital at Westmead | |
| Sydney, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Royal Childrens Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Women's and Children's Hospital-Adelaide | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6008 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Janeway Child Health Centre | |
| Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Chedoke-McMaster Hospitals | |
| Hamilton, Ontario, Canada, L8S 4L8 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Children's Hospital | |
| London, Ontario, Canada, N6A 5W9 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| The Montreal Children's Hospital of the MUHC | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Centre Hospitalier Universitaire Sainte-Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Centre Hospitalier Universitaire de Quebec | |
| Ste-Foy, Quebec, Canada, G1V 4G2 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| New Zealand | |
| Starship Children's Hospital | |
| Grafton, Auckland, New Zealand, 1145 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8011 | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Patrick Leavey, MD | Children's Oncology Group |
More Information
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01231906 History of Changes |
| Other Study ID Numbers: |
AEWS1031 NCI-2011-02611 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-AEWS1031 ( Other Identifier: Children's Oncology Group ) CDR0000687639 ( Other Identifier: Clinical Trials.gov ) AEWS1031 ( Other Identifier: Children's Oncology Group ) AEWS1031 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 29, 2010 |
| Last Updated: | February 8, 2017 |
Additional relevant MeSH terms:
|
Neoplasms Sarcoma Sarcoma, Ewing Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Kidney Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |
Neoplasms, Glandular and Epithelial Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Cyclophosphamide Ifosfamide Isophosphamide mustard Liposomal doxorubicin Etoposide phosphate Doxorubicin Etoposide Vincristine Topotecan |
ClinicalTrials.gov processed this record on July 28, 2017