Yhdistelmäkemoterapia ganitumabin kanssa tai ilman sitä hoidettaessa potilaita, joilla on äskettäin diagnosoitu metastaattinen Ewing-sarkooma
Satunnaistettu vaiheen 3 koe, jossa arvioidaan IGF-1R-monoklonaalisen vasta-aineen ganitumabi (AMG 479, NSC# 750008) lisäämistä moniainekemoterapiaan potilaille, joilla on äskettäin diagnosoitu metastaattinen Ewing-sarkooma
This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
- Metastaattinen pahanlaatuinen kasvain luussa
- Pehmeiden kudosten perifeerinen primitiivinen neuroektodermaalinen kasvain
- Metastaattinen pahanlaatuinen kasvain keuhkoissa
- Metastaattinen Ewing-sarkooma
- Metastaattinen pahanlaatuinen kasvain luuytimessä
- Metastaattinen perifeerinen primitiivinen neuroektodermaalinen luukasvain
Interventio / Hoito
Interventio / Hoito
- Lääke: Cyclophosphamide
- Lääke: Doxorubicin Hydrochloride
- Lääke: Doxorubicin
- Lääke: Vincristine
- Lääke: Vincristine Sulfate
- Lääke: Etoposide
- Lääke: Etoposide Phosphate
- Säteily: External Beam Radiation Therapy
- Lääke: Ifosfamide
- Säteily: Stereotactic Radiosurgery
- Menettely: Therapeutic Surgical Procedure
- Biologinen: Ganitumab
Yksityiskohtainen kuvaus
PRIMARY OBJECTIVES:
I. To determine if event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab (AMG 479).
SECONDARY OBJECTIVES:
I. To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma.
II. To compare overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.
EXPLORATORY OBJECTIVES:
I. To compare bone marrow response rates in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.
II. To describe the toxicity of 6 months of ganitumab monotherapy as maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.
III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg.
IV. To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma.
V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
VI. To determine if EFS, overall survival, and bone marrow response rates differ based on protein, deoxyribose nucleic acid (DNA), and ribonucleic acid (RNA) marker in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma.
VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab.
IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET) to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic resonance imaging (MRI).
X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.
XI. To collect data on institutional testing for Ewing sarcoma breakpoint region 1 (EWSR1) translocation status in patients enrolling on study.
XII. To explore the capacity of plasma cell-free DNA analysis to detect tumor-specific genetic changes at initial diagnosis and after initiation of protocol therapy.
XIII. To collect a population of bone marrow metastatic tumor cells by flow cytometry for genomic profiling.
OUTLINE: Patients are randomized to 1 of 2 treatment regimens. (As of 3/20/2019, the study is closed to accrual and patients in Regimen B no longer receive ganitumab.)
REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and ifosfamide and etoposide phosphate [IE]):
INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1, doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2, and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9, and ifosfamide IV over 1 hour on days 1 to 5 and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.
LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7, cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13, ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15, and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.
METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or external beam radiation therapy (EBRT).
REGIMEN B (VDC/IE + ganitumab):
INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.
LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.
METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.
MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.
After completion of study treatment, patients are followed for 10 years.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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-
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Québec, Kanada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Calgary, Alberta, Kanada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Kanada, T6G 2B7
- University of Alberta Hospital
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British Columbia
-
Vancouver, British Columbia, Kanada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
-
Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
-
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
- Janeway Child Health Centre
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-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Kanada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Kanada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal, Quebec, Kanada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Kanada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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-
-
-
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San Juan, Puerto Rico, 00926
- University Pediatric Hospital
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San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
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-
-
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, Yhdysvallat, 36604
- USA Health Strada Patient Care Center
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-
Alaska
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Anchorage, Alaska, Yhdysvallat, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, Yhdysvallat, 85202
- Banner Children's at Desert
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Phoenix, Arizona, Yhdysvallat, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, Yhdysvallat, 85719
- Banner University Medical Center - Tucson
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Yuma, Arizona, Yhdysvallat, 85364
- Onvida Health Yuma Medical Center
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Arkansas
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Hot Springs, Arkansas, Yhdysvallat, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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Little Rock, Arkansas, Yhdysvallat, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, Yhdysvallat, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, Yhdysvallat, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Yhdysvallat, 92354
- Loma Linda University Medical Center
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Long Beach, California, Yhdysvallat, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, Yhdysvallat, 90027
- Children's Hospital Los Angeles
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Madera, California, Yhdysvallat, 93636
- Valley Children's Hospital
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Oakland, California, Yhdysvallat, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, Yhdysvallat, 94611
- Kaiser Permanente-Oakland
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Orange, California, Yhdysvallat, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Yhdysvallat, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, Yhdysvallat, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Yhdysvallat, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Yhdysvallat, 92123
- Rady Children's Hospital - San Diego
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San Francisco, California, Yhdysvallat, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, Yhdysvallat, 94143
- UCSF Medical Center-Parnassus
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Torrance, California, Yhdysvallat, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Yhdysvallat, 80045
- Children's Hospital Colorado
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Colorado Springs, Colorado, Yhdysvallat, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Yhdysvallat, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Yhdysvallat, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Denver, Colorado, Yhdysvallat, 80210
- AdventHealth Porter
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Durango, Colorado, Yhdysvallat, 81301
- Mercy Medical Center
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Durango, Colorado, Yhdysvallat, 81301
- CommonSpirit Cancer Center Mercy
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Golden, Colorado, Yhdysvallat, 80401
- Mountain Blue Cancer Care Center
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Lakewood, Colorado, Yhdysvallat, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Yhdysvallat, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Yhdysvallat, 80122
- AdventHealth Littleton
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Longmont, Colorado, Yhdysvallat, 80501
- Longmont United Hospital
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Longmont, Colorado, Yhdysvallat, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Yhdysvallat, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Yhdysvallat, 80138
- AdventHealth Parker
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Pueblo, Colorado, Yhdysvallat, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Yhdysvallat, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, Yhdysvallat, 80260
- Rocky Mountain Cancer Centers-Thornton
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Connecticut
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Hartford, Connecticut, Yhdysvallat, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, Yhdysvallat, 06520
- Yale University
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Delaware
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Wilmington, Delaware, Yhdysvallat, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Yhdysvallat, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Myers, Florida, Yhdysvallat, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, Yhdysvallat, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Yhdysvallat, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, Yhdysvallat, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, Yhdysvallat, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Yhdysvallat, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, Yhdysvallat, 32827
- Nemours Children's Hospital
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Orlando, Florida, Yhdysvallat, 32803
- AdventHealth Orlando
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Orlando, Florida, Yhdysvallat, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, Yhdysvallat, 32504
- Nemours Children's Clinic - Pensacola
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St. Petersburg, Florida, Yhdysvallat, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Yhdysvallat, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, Yhdysvallat, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Augusta, Georgia, Yhdysvallat, 30912
- Augusta University Medical Center
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Savannah, Georgia, Yhdysvallat, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Yhdysvallat, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Yhdysvallat, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, Yhdysvallat, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Aurora, Illinois, Yhdysvallat, 60504
- Rush-Copley Medical Center
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Chicago, Illinois, Yhdysvallat, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Yhdysvallat, 60612
- University of Illinois
-
Chicago, Illinois, Yhdysvallat, 60611
- Lurie Children's Hospital-Chicago
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Danville, Illinois, Yhdysvallat, 61832
- Carle at The Riverfront
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Effingham, Illinois, Yhdysvallat, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Yhdysvallat, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Yhdysvallat, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, Yhdysvallat, 62864
- SSM Health Good Samaritan
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Oak Lawn, Illinois, Yhdysvallat, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, Yhdysvallat, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, Yhdysvallat, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, Yhdysvallat, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Yhdysvallat, 62702
- Saint John's Hospital
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Springfield, Illinois, Yhdysvallat, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Yhdysvallat, 61801
- Carle Cancer Center
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Urbana, Illinois, Yhdysvallat, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Yhdysvallat, 60560
- Rush-Copley Healthcare Center
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Indiana
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Evansville, Indiana, Yhdysvallat, 47713
- Deaconess Clinic Downtown
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Indianapolis, Indiana, Yhdysvallat, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, Yhdysvallat, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Michigan City, Indiana, Yhdysvallat, 46360
- Franciscan Saint Anthony Health-Michigan City
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Michigan City, Indiana, Yhdysvallat, 46360
- Woodland Cancer Care Center
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Newburgh, Indiana, Yhdysvallat, 47630
- Chancellor Center for Oncology
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Iowa
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Clive, Iowa, Yhdysvallat, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Yhdysvallat, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Yhdysvallat, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Yhdysvallat, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Yhdysvallat, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Yhdysvallat, 50309
- Blank Children's Hospital
-
Des Moines, Iowa, Yhdysvallat, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Iowa City, Iowa, Yhdysvallat, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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West Des Moines, Iowa, Yhdysvallat, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Bardstown, Kentucky, Yhdysvallat, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
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Corbin, Kentucky, Yhdysvallat, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Yhdysvallat, 40536
- University of Kentucky/Markey Cancer Center
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Lexington, Kentucky, Yhdysvallat, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Yhdysvallat, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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London, Kentucky, Yhdysvallat, 40741
- CommonSpirit Saint Joseph Hospital London
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Louisville, Kentucky, Yhdysvallat, 40202
- Jewish Hospital
-
Louisville, Kentucky, Yhdysvallat, 40202
- Norton Children's Hospital
-
Louisville, Kentucky, Yhdysvallat, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, Yhdysvallat, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Yhdysvallat, 40165
- Jewish Hospital Medical Center South
-
-
Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70121
- Ochsner Medical Center Jefferson
-
New Orleans, Louisiana, Yhdysvallat, 70118
- Children's Hospital New Orleans
-
-
Maine
-
Bangor, Maine, Yhdysvallat, 04401
- Eastern Maine Medical Center
-
Scarborough, Maine, Yhdysvallat, 04074
- Maine Children's Cancer Program
-
-
Maryland
-
Baltimore, Maryland, Yhdysvallat, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Yhdysvallat, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bethesda, Maryland, Yhdysvallat, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Yhdysvallat, 02114
- Massachusetts General Hospital Cancer Center
-
Springfield, Massachusetts, Yhdysvallat, 01199
- Baystate Medical Center
-
Worcester, Massachusetts, Yhdysvallat, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- C S Mott Children's Hospital
-
Ann Arbor, Michigan, Yhdysvallat, 48109
- University of Michigan Rogel Cancer Center
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Battle Creek, Michigan, Yhdysvallat, 49017
- Bronson Battle Creek
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Detroit, Michigan, Yhdysvallat, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, Yhdysvallat, 48236
- Henry Ford Health Saint John Hospital
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Flint, Michigan, Yhdysvallat, 48503
- Hurley Medical Center
-
Grand Rapids, Michigan, Yhdysvallat, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Yhdysvallat, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, Yhdysvallat, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, Yhdysvallat, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Yhdysvallat, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Yhdysvallat, 49048
- Beacon Kalamazoo
-
Muskegon, Michigan, Yhdysvallat, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Yhdysvallat, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Port Huron, Michigan, Yhdysvallat, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Yhdysvallat, 48060
- Huron Medical Center PC
-
Reed City, Michigan, Yhdysvallat, 49677
- Corewell Health Reed City Hospital
-
Royal Oak, Michigan, Yhdysvallat, 48073
- Corewell Health Children's
-
Saint Joseph, Michigan, Yhdysvallat, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Yhdysvallat, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Yhdysvallat, 49684
- Munson Medical Center
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Minnesota
-
Duluth, Minnesota, Yhdysvallat, 55805
- Essentia Health Cancer Center
-
Minneapolis, Minnesota, Yhdysvallat, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Minneapolis, Minnesota, Yhdysvallat, 55455
- University of Minnesota/Masonic Cancer Center
-
Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic in Rochester
-
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Mississippi
-
Jackson, Mississippi, Yhdysvallat, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Bolivar, Missouri, Yhdysvallat, 65613
- Central Care Cancer Center - Bolivar
-
Branson, Missouri, Yhdysvallat, 65616
- Cox Cancer Center Branson
-
Columbia, Missouri, Yhdysvallat, 65212
- University of Missouri Children's Hospital
-
Joplin, Missouri, Yhdysvallat, 64804
- Freeman Health System
-
Joplin, Missouri, Yhdysvallat, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Yhdysvallat, 64108
- Children's Mercy Hospitals and Clinics
-
Rolla, Missouri, Yhdysvallat, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Yhdysvallat, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Yhdysvallat, 64506
- Heartland Regional Medical Center
-
Springfield, Missouri, Yhdysvallat, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Yhdysvallat, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Yhdysvallat, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Yhdysvallat, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Yhdysvallat, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
-
Bellevue, Nebraska, Yhdysvallat, 68123
- Nebraska Medicine-Bellevue
-
Grand Island, Nebraska, Yhdysvallat, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Yhdysvallat, 68847
- CHI Health Good Samaritan
-
Kearney, Nebraska, Yhdysvallat, 68845
- Fred and Pamela Buffett Cancer Center - Kearney
-
Lincoln, Nebraska, Yhdysvallat, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68118
- Nebraska Medicine-Village Pointe
-
Omaha, Nebraska, Yhdysvallat, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Yhdysvallat, 68114
- Children's Hospital and Medical Center of Omaha
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Omaha, Nebraska, Yhdysvallat, 68122
- Hematology and Oncology Consultants PC
-
Papillion, Nebraska, Yhdysvallat, 68046
- Midlands Community Hospital
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Nevada
-
Carson City, Nevada, Yhdysvallat, 89703
- Carson Tahoe Regional Medical Center
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Henderson, Nevada, Yhdysvallat, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
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Las Vegas, Nevada, Yhdysvallat, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Yhdysvallat, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Yhdysvallat, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Yhdysvallat, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89128
- Ann M Wierman MD LTD
-
Pahrump, Nevada, Yhdysvallat, 89048
- Hope Cancer Care of Nevada-Pahrump
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Reno, Nevada, Yhdysvallat, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Yhdysvallat, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Yhdysvallat, 89509
- Radiation Oncology Associates
-
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New Hampshire
-
Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Hackensack, New Jersey, Yhdysvallat, 07601
- Hackensack University Medical Center
-
Morristown, New Jersey, Yhdysvallat, 07960
- Morristown Medical Center
-
New Brunswick, New Jersey, Yhdysvallat, 08901
- Saint Peter's University Hospital
-
New Brunswick, New Jersey, Yhdysvallat, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Newark, New Jersey, Yhdysvallat, 07112
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, Yhdysvallat, 07503
- Saint Joseph's Regional Medical Center
-
-
New York
-
Albany, New York, Yhdysvallat, 12208
- Albany Medical Center
-
Buffalo, New York, Yhdysvallat, 14263
- Roswell Park Cancer Institute
-
Glens Falls, New York, Yhdysvallat, 12801
- Glens Falls Hospital
-
Mineola, New York, Yhdysvallat, 11501
- NYU Langone Hospital - Long Island
-
New Hyde Park, New York, Yhdysvallat, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
New York, New York, Yhdysvallat, 10029
- Mount Sinai Hospital
-
New York, New York, Yhdysvallat, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Yhdysvallat, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Yhdysvallat, 14642
- University of Rochester
-
Stony Brook, New York, Yhdysvallat, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Yhdysvallat, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Yhdysvallat, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Yhdysvallat, 10467
- Children's Hospital at Montefiore
-
The Bronx, New York, Yhdysvallat, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Yhdysvallat, 10461
- Montefiore Medical Center-Weiler Hospital
-
Valhalla, New York, Yhdysvallat, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, Yhdysvallat, 28801
- Mission Hospital
-
Chapel Hill, North Carolina, Yhdysvallat, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Yhdysvallat, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Durham, North Carolina, Yhdysvallat, 27710
- Duke University Medical Center
-
Winston-Salem, North Carolina, Yhdysvallat, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Fargo, North Dakota, Yhdysvallat, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Yhdysvallat, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Yhdysvallat, 45229
- Cincinnati Children's Hospital Medical Center
-
Cincinnati, Ohio, Yhdysvallat, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Yhdysvallat, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Yhdysvallat, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Yhdysvallat, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Yhdysvallat, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Yhdysvallat, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, Yhdysvallat, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, Yhdysvallat, 45404
- Dayton Children's Hospital
-
Toledo, Ohio, Yhdysvallat, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Yhdysvallat, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Portland, Oregon, Yhdysvallat, 97239
- Oregon Health and Science University
-
Portland, Oregon, Yhdysvallat, 97227
- Legacy Emanuel Children's Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Yhdysvallat, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Yhdysvallat, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, Yhdysvallat, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Yhdysvallat, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Yhdysvallat, 19134
- Saint Christopher's Hospital for Children
-
Philadelphia, Pennsylvania, Yhdysvallat, 19102
- Drexel University School of Medicine
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
Rhode Island
-
Providence, Rhode Island, Yhdysvallat, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Yhdysvallat, 29425
- Medical University of South Carolina
-
Columbia, South Carolina, Yhdysvallat, 29203
- Prisma Health Richland Hospital
-
Greenville, South Carolina, Yhdysvallat, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Yhdysvallat, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Yhdysvallat, 29605
- BI-LO Charities Children's Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Yhdysvallat, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, Yhdysvallat, 37403
- T C Thompson Children's Hospital
-
Chattanooga, Tennessee, Yhdysvallat, 37404
- Memorial Hospital
-
Hixson, Tennessee, Yhdysvallat, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Knoxville, Tennessee, Yhdysvallat, 37916
- East Tennessee Childrens Hospital
-
Memphis, Tennessee, Yhdysvallat, 38105
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, Yhdysvallat, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Yhdysvallat, 37203
- The Children's Hospital at TriStar Centennial
-
Ooltewah, Tennessee, Yhdysvallat, 37363
- Memorial GYN Plus
-
-
Texas
-
Austin, Texas, Yhdysvallat, 78723
- Dell Children's Medical Center of Central Texas
-
Bryan, Texas, Yhdysvallat, 77802
- Saint Joseph Regional Cancer Center
-
Corpus Christi, Texas, Yhdysvallat, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, Yhdysvallat, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Yhdysvallat, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, Yhdysvallat, 79905
- El Paso Children's Hospital
-
Fort Worth, Texas, Yhdysvallat, 76104
- Cook Children's Medical Center
-
Houston, Texas, Yhdysvallat, 77030
- UT MD Anderson Cancer Center
-
Houston, Texas, Yhdysvallat, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, Yhdysvallat, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, Yhdysvallat, 79415
- UMC Cancer Center / UMC Health System
-
Lubbock, Texas, Yhdysvallat, 79430
- Texas Tech University Health Sciences Center-Lubbock
-
San Antonio, Texas, Yhdysvallat, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Yhdysvallat, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, Yhdysvallat, 78229
- Methodist Children's Hospital of South Texas
-
Temple, Texas, Yhdysvallat, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, Yhdysvallat, 84113
- Primary Children's Hospital
-
-
Vermont
-
Berlin Corners, Vermont, Yhdysvallat, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Yhdysvallat, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Yhdysvallat, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Falls Church, Virginia, Yhdysvallat, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, Yhdysvallat, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, Yhdysvallat, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Yhdysvallat, 23298
- VCU Massey Comprehensive Cancer Center
-
Roanoke, Virginia, Yhdysvallat, 24014
- Carilion Children's
-
-
Washington
-
Burien, Washington, Yhdysvallat, 98166
- Saint Anne Hospital
-
Enumclaw, Washington, Yhdysvallat, 98022
- Saint Elizabeth Hospital
-
Federal Way, Washington, Yhdysvallat, 98003
- Saint Francis Hospital
-
Lakewood, Washington, Yhdysvallat, 98499
- Saint Clare Hospital
-
Poulsbo, Washington, Yhdysvallat, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, Yhdysvallat, 98105
- Seattle Children's Hospital
-
Silverdale, Washington, Yhdysvallat, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Spokane, Washington, Yhdysvallat, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Tacoma, Washington, Yhdysvallat, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Yhdysvallat, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Yhdysvallat, 98431
- Madigan Army Medical Center
-
Tacoma, Washington, Yhdysvallat, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
-
West Virginia
-
Morgantown, West Virginia, Yhdysvallat, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Green Bay, Wisconsin, Yhdysvallat, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Marinette, Wisconsin, Yhdysvallat, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Yhdysvallat, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Yhdysvallat, 53226
- Children's Hospital of Wisconsin
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site
-
For the purpose of this study metastatic disease is defined as one or more of the following:
-
Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor; skip lesions in the same bone as the primary tumor do not constitute metastatic disease; skip lesions in an adjacent bone are considered bone metastases; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed
-
Contralateral pleural effusion and/or 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 lesion is biopsied and negative for tumor
- Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor
-
Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on hematoxylin and eosin (H&E) stains; in the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study
- This study requires bilateral bone marrow biopsies at study entry; the suggested approach for patients with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy)
-
Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or computed tomography (CT) (whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole body technetium bone scans may be performed at the discretion of the investigator and are not required; for patients without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry
-
-
Patients must have adequate tumor tissue to meet the minimum requirement for submission
-
Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required
-
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 excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):
- Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females
- Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and females
- Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females
- Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females
- Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females
- Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females
- Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for females
- Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for females
-
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment), and
-
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)
-
Shortening fraction of >= 27% or
-
Ejection fraction of >= 50%
-
Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
-
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
Exclusion Criteria:
- Patients with regional node involvement as their only site of disease beyond the primary tumor will not be eligible
- Patients whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord) are not eligible
- Patients who have received prior chemotherapy or radiation therapy are not eligible
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy
- Patients with known pre-existing diabetes mellitus will be excluded from study
- Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: Regimen A (VDC/IE)
See Design Details. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo EBRT
Muut nimet:
Given IV
Muut nimet:
Undergo SBRT
Muut nimet:
Undergo surgery |
|
Kokeellinen: Regimen B (VDC/IE + ganitumab)
INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. |
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Given IV
Muut nimet:
Undergo EBRT
Muut nimet:
Given IV
Muut nimet:
Undergo SBRT
Muut nimet:
Undergo surgery Given IV
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Event-free Survival
Aikaikkuna: 5 years after enrollment
|
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. |
5 years after enrollment
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival
Aikaikkuna: 5 years after enrollment
|
Time from study enrollment to death or last patient contact. |
5 years after enrollment
|
|
Frequency of Toxicity-events
Aikaikkuna: Up to 202 days
|
The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. |
Up to 202 days
|
Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
Aikaikkuna: Up to 10 years
|
In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median. |
Up to 10 years
|
|
Tumor Cell Surface IGF-1R Expression
Aikaikkuna: Up to 307 days
|
Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively. |
Up to 307 days
|
|
Germline Polymorphisms in EGFR
Aikaikkuna: Up to 10 years
|
EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab. |
Up to 10 years
|
|
EWS Translocation
Aikaikkuna: Up to 10 years
|
The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated. |
Up to 10 years
|
|
Circulating Tumor DNA (ctDNA) Testing
Aikaikkuna: Up to 202 days
|
Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods. |
Up to 202 days
|
|
Serial Genomic Profiling
Aikaikkuna: Up to 307 days
|
Will be identified by flow cytometry. Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented. |
Up to 307 days
|
|
Occurrence of Sinusoidal Obstructive Disease (SOS) Associated With the Addition of Ganitumab to VDC/IE
Aikaikkuna: Up to 202 days
|
The number of induction and maintenance cycles received by patients randomized to the experimental therapy where SOS is observed. Only patients who receive all reporting period therapy or experience SOS will contribute to this outcome measure. |
Up to 202 days
|
|
Frequency of Resolution of Bone Marrow Metastases
Aikaikkuna: Up to 84 days
|
The number of patients who are enrolled with bone marrow metastases whose bone marrow disease is not detected after evaluation at the time of of first local control measure or the end of the Induction reporting period, whichever comes first. Only eligible patients who receive at least one dose of randomized treatment assignment will be considered for this measure. |
Up to 84 days
|
|
Frequency of Toxicity Events During Ganitumab Maintenance
Aikaikkuna: Up to 307 days
|
The number of induction or consolidation reporting periods in which a CTC version 4 codeable non-hematological adverse event, grade 3 left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. |
Up to 307 days
|
|
Trough Levels of Serum Ganitumab
Aikaikkuna: Up to 15 days
|
Trough levels of serum ganitumab prior to the second dose of ganitumab during induction obtained will be categorized as less than 10 micrograms per milliliter or greater than or equal to 10 micrograms per milliliter. This analysis will be conducted for the first 10 eligible patients who receive ganitumab. |
Up to 15 days
|
|
Proportion of Patients Who Successfully Receive Planned Stereotactic Body Radiotherapy (SBRT)
Aikaikkuna: 202 days
|
A patient who has SBRT planned for at least one metastatic site and receives successful SBRT treatment to at least 85% of metastatic sites in the treatment plan. Successful treatment is determined by IROC review criteria. Only eligible patients start the metastatic site radiation reporting period will be considered for this outcome measure. |
202 days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Steven G DuBois, Children's Oncology Group
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- DuBois SG, Krailo MD, Glade-Bender J, Buxton A, Laack N, Randall RL, Chen HX, Seibel NL, Boron M, Terezakis S, Hill-Kayser C, Hayes A, Reid JM, Teot L, Rakheja D, Womer R, Arndt C, Lessnick SL, Crompton BD, Kolb EA, Daldrup-Link H, Eutsler E, Reed DR, Janeway KA, Gorlick RG. Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2023 Apr 10;41(11):2098-2107. doi: 10.1200/JCO.22.01815. Epub 2023 Jan 20.
- von Kruchten R, DelRocco NJ, Adams LC, Singh SB, Varniab ZS, Bender JG, Krailo MD, DuBois S, Daldrup-Link HE. Role of diffusion-weighted MRI in assessing Ewing sarcoma treatment response: Findings from a COG phase III trial. Magn Reson Imaging. 2026 Oct;132:110706. doi: 10.1016/j.mri.2026.110706. Epub 2026 May 27.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvioitu)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat
- Neoplasmat histologisen tyypin mukaan
- Sarkooma
- Neoplasmat, side- ja pehmytkudokset
- Osteosarkooma
- Kasvaimet, luukudos
- Kasvaimet, sidekudos
- Sarkooma, Ewing
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Tutkintatekniikat
- Terapeuttiset lääkkeet
- Kirurgiset toimenpiteet, operatiivinen
- Hiilivety
- Hiilivedyt, sykliset
- Hiilihydraatit
- Fyysiset ilmiöt
- Alkaloidit
- Podofyllitoksiinia
- Tetrahydronaftaleenit
- Naftaleenit
- Poltisykliset aromaattiset hiilivedyt
- Hiilivedyt, aromaattiset
- Polisykliset yhdisteet
- Glukosidit
- Glykosidit
- Indolit
- Organisaatiot
- Terveydenhuollon taloustiede ja organisaatiot
- Fosforamidi -sinapit
- Typpisinappiyhdisteet
- Sinappiyhdisteet
- Hiilivety, halogenoitu
- Fosforamidit
- Organofosforiyhdisteet
- Vinca -alkaloidit
- Secologaniinin tryptamiini -alkaloidit
- Indolialkaloidit
- Indolitsidiinit
- Indolisoija
- Antrasykliinit
- Nafthaceenit
- Aminoglykosidit
- Sädehoito
- Stereotaksiset tekniikat
- Neurokirurgiset toimenpiteet
- Daunorubisiini
- Oksatsiinit
- Syklofosfamidi
- Etoposidi
- Doksorubisiini
- Vincristine
- Ifosfamidi
- Säteily
- Kongressit aiheena
- Radiokirurgia
- etoposidifosfaatti
- ganitumabi
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- NCI-2014-02380
- U10CA180886 (Yhdysvaltain NIH-apuraha/sopimus)
- U10CA098543 (Yhdysvaltain NIH-apuraha/sopimus)
- NCI-2014-02380 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))
- AEWS1221 (Muu tunniste: CTEP)
- s15-00442
- AEWS1221
- AEWS1221 (Muu tunniste: Children's Oncology Group)
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