Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
May 18, 2026 updated by: Children's Oncology Group
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor.
Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading.
Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Sometimes, after surgery, the tumor may not need additional treatment until it progresses.
In this case, observation may be sufficient.
Study Overview
Status
Completed
Intervention / Treatment
- Procedure: Magnetic Resonance Imaging
- Procedure: Computed Tomography
- Procedure: Biospecimen Collection
- Drug: Vincristine Sulfate
- Procedure: Therapeutic Conventional Surgery
- Drug: Doxorubicin Hydrochloride
- Biological: Dactinomycin
- Procedure: Chest Radiography
- Radiation: 3-Dimensional Conformal Radiation Therapy
- Procedure: Ultrasound Imaging
- Procedure: Echocardiography Test
Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk).
SECONDARY OBJECTIVES:
I. Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker.
II. Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only.
III. Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse.
IV. Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk).
STRATUM I: (very low-risk disease) Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks.
STRATUM II: (standard-risk, stage I or II disease with adverse biological marker) Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks.
STRATUM III: (standard-risk, stage III disease) Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks.
Additionally, patients undergo chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI), ultrasound, echocardiography, and blood sample collection throughout the study.
After completion of study treatment, patients are followed periodically for up to 8 years.
Study Type
Interventional
Enrollment (Actual)
808
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australia, 2145
- The Children's Hospital at Westmead
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital
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Herston, Queensland, Australia, 4029
- Royal Children's Hospital-Brisbane
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South Brisbane, Queensland, Australia, 4101
- Queensland Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital-Adelaide
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6008
- Princess Margaret Hospital for Children
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Québec, Canada, G1V 4G2
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A 5W9
- Children's Hospital
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London, Ontario, Canada, N6K 1C2
- Victoria Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Canada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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-
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Petah Tikua, Israel, 49202
- Schneider Children's Medical Center of Israel
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-
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-
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Auckland
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Grafton, Auckland, New Zealand, 1145
- Starship Children's Hospital
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San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
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Bern, Switzerland, 3010
- Swiss Pediatric Oncology Group - Bern
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, United States, 36604
- USA Health Strada Patient Care Center
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, United States, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, United States, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Madera, California, United States, 93636
- Valley Children's Hospital
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Oakland, California, United States, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
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Oakland, California, United States, 94607
- Children's Oncology Group
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, United States, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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San Francisco, California, United States, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, United States, 94143
- UCSF Medical Center-Parnassus
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Santa Barbara, California, United States, 93102
- Santa Barbara Cottage Hospital
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Torrance, California, United States, 90502
- Harbor-University of California at Los Angeles Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, United States, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33908
- Golisano Children's Hospital of Southwest Florida
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Fort Myers, Florida, United States, 33901
- Lee Memorial Health System
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Gainesville, Florida, United States, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, United States, 33155
- Nicklaus Children's Hospital
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, United States, 33176
- Miami Cancer Institute
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Orlando, Florida, United States, 32806
- Orlando Health Cancer Institute
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Orlando, Florida, United States, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, United States, 32504
- Sacred Heart Hospital
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Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
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St. Petersburg, Florida, United States, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, United States, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Augusta, Georgia, United States, 30912
- Augusta University Medical Center
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, United States, 96859
- Tripler Army Medical Center
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Idaho
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Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital-Chicago
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Oak Lawn, Illinois, United States, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, United States, 60068
- Advocate Lutheran General Hospital
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Park Ridge, Illinois, United States, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, United States, 50309
- Blank Children's Hospital
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, United States, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, United States, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, United States, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, United States, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States, 02111
- Tufts Children's Hospital
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, United States, 48236
- Henry Ford Health Saint John Hospital
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East Lansing, Michigan, United States, 48823
- Michigan State University
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, United States, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49008
- Kalamazoo Center for Medical Studies
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Royal Oak, Michigan, United States, 48073
- Corewell Health William Beaumont University Hospital
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Royal Oak, Michigan, United States, 48073
- Corewell Health Children's
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Children's Hospital
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, United States, 63110
- Washington University School of Medicine
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St Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, United States, 89120
- Nevada Cancer Research Foundation NCORP
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Livingston, New Jersey, United States, 07039
- Saint Barnabas Medical Center
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- Saint Joseph's Regional Medical Center
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Summit, New Jersey, United States, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico Cancer Center
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New York
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Albany, New York, United States, 12208
- Albany Medical Center
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Brooklyn, New York, United States, 11201
- Brooklyn Hospital Center
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Mineola, New York, United States, 11501
- NYU Langone Hospital - Long Island
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New Hyde Park, New York, United States, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai Hospital
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New York, New York, United States, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, United States, 10065
- NYP/Weill Cornell Medical Center
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New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, United States, 14642
- University of Rochester
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Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
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The Bronx, New York, United States, 10467
- Montefiore Medical Center - Moses Campus
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Valhalla, New York, United States, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Greenville, North Carolina, United States, 27834
- East Carolina University
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44106
- Rainbow Babies and Childrens Hospital
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Toledo, Ohio, United States, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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Toledo, Ohio, United States, 43614
- University of Toledo
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Toledo, Ohio, United States, 43608
- Mercy Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97227
- Legacy Emanuel Children's Hospital
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S Hershey Medical Center
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Hershey, Pennsylvania, United States, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
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Greenville, South Carolina, United States, 29605
- Greenville Cancer Treatment Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
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Memphis, Tennessee, United States, 38105
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Amarillo, Texas, United States, 79106
- Texas Tech University Health Sciences Center-Amarillo
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Austin, Texas, United States, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Lubbock, Texas, United States, 79410
- Covenant Children's Hospital
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Methodist Children's Hospital of South Texas
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont and State Agricultural College
-
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Cancer Center
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center - Portsmouth
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Richmond, Virginia, United States, 23298
- VCU Massey Comprehensive Cancer Center
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Roanoke, Virginia, United States, 24014
- Carilion Children's
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, United States, 98405
- Mary Bridge Children's Hospital and Health Center
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25304
- West Virginia University Charleston Division
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
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Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 29 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Histologically confirmed Wilms' tumor
- Newly diagnosed stage I-III disease
- Favorable histology
- No moderate- or high-risk Wilms' predisposition syndromes
Must meet 1 of the following disease stratification categories:
Very low-risk disease
- Stage I disease
- Age < 2 years
- Tumor weight < 550 g
- Regional lymph nodes histologically negative (must have been sampled)
- No pulmonary metastases on CT scan of chest
- No synchronous bilateral Wilms tumors (Stage V)
Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following:
- Aniridia
- Beckwith-Wiedemann syndrome
- Simpson-Golabi-Behmel syndrome
- Denys-Drash syndrome or other associated genito-urinary anomalies
- Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child < 1 year of age
- Diffuse hyperplastic perilobar nephroblastomatosis
Standard-risk disease meeting 1 of the following criteria:
Disease does not require radiotherapy
- LOH at chromosomes 1p and 16q for stage I or II
Stage I disease meeting 1 of the following criteria:
- Age ≥ 2 years to age < 30 years
- Tumor weight ≥ 500 g
Stage II disease
- Age < 30 years
- Any tumor weight
Disease requires radiotherapy
- No LOH at chromosomes 1p and 16q*
- Stage III disease
- Must be enrolled on protocol COG-AREN03B2
- Karnofsky performance status (PS) 50-100% for patients > 16 years old
- Lansky PS 50-100% for patients ≤ 16 years old
- Bilirubin (direct) ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT < 2.5 times ULN
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram (standard-risk disease)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patient must use effective contraception
No prior tumor-directed chemotherapy or radiotherapy
- Patients transferring from AREN03B2 with LOH 1p and 16q allowed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stratum I (very low-risk disease)
Patients undergo nephrectomy only.
If they meet criteria, they are then observed periodically for 5 years.
Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III.
Patients with no metachronous renal disease receive radiotherapy.
Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy.
Treatment continues for up to 25 weeks.
Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo surgery
Given IV
Other Names:
Given IV
Other Names:
Undergo chest X-ray
Other Names:
Patients undergo radiotherapy
Other Names:
Undergo ultrasound
Other Names:
Undergo echocardiography
Other Names:
|
|
Experimental: Stratum II (standard-risk, stage I or II)
Patients undergo nephrectomy.
Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses.
Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin.
Treatment continues for up to 25 weeks.
Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo surgery
Given IV
Other Names:
Given IV
Other Names:
Undergo chest X-ray
Other Names:
Patients undergo radiotherapy
Other Names:
Undergo ultrasound
Other Names:
Undergo echocardiography
Other Names:
|
|
Experimental: Stratum III (standard-risk, stage III)
Patients undergo nephrectomy, if feasible, or biopsy.
For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13.
Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses.
Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride.
Patients undergo radiotherapy over 5-7 days after nephrectomy.
Treatment continues for up to 25 weeks.
Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo surgery
Given IV
Other Names:
Given IV
Other Names:
Undergo chest X-ray
Other Names:
Patients undergo radiotherapy
Other Names:
Undergo ultrasound
Other Names:
Undergo echocardiography
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event Free Survival Probability
Time Frame: 4 years
|
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
|
4 years
|
|
Overall Survival (OS) Probability
Time Frame: 4 years
|
Probability of being alive after 4 years in the study.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Contralateral Kidney Lesions
Time Frame: During follow-up
|
Number of contralateral kidney lesions during follow-up.
|
During follow-up
|
|
Incidence of Renal Failure
Time Frame: During follow-up
|
Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
|
During follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth A Mullen, Children's Oncology Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dix DB, Fernandez CV, Chi YY, Mullen EA, Geller JI, Gratias EJ, Khanna G, Kalapurakal JA, Perlman EJ, Seibel NL, Ehrlich PF, Malogolowkin M, Anderson J, Gastier-Foster J, Shamberger RC, Kim Y, Grundy PE, Dome JS; AREN0532 and AREN0533 study committees. Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children's Oncology Group AREN0532 and AREN0533 Study Report. J Clin Oncol. 2019 Oct 20;37(30):2769-2777. doi: 10.1200/JCO.18.01972. Epub 2019 Aug 26.
- Fernandez CV, Perlman EJ, Mullen EA, Chi YY, Hamilton TE, Gow KW, Ferrer FA, Barnhart DC, Ehrlich PF, Khanna G, Kalapurakal JA, Bocking T, Huff V, Tian J, Geller JI, Grundy PE, Anderson JR, Dome JS, Shamberger RC. Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532. Ann Surg. 2017 Apr;265(4):835-840. doi: 10.1097/SLA.0000000000001716.
- Fernandez CV, Mullen EA, Chi YY, Ehrlich PF, Perlman EJ, Kalapurakal JA, Khanna G, Paulino AC, Hamilton TE, Gow KW, Tochner Z, Hoffer FA, Withycombe JS, Shamberger RC, Kim Y, Geller JI, Anderson JR, Grundy PE, Dome JS. Outcome and Prognostic Factors in Stage III Favorable-Histology Wilms Tumor: A Report From the Children's Oncology Group Study AREN0532. J Clin Oncol. 2018 Jan 20;36(3):254-261. doi: 10.1200/JCO.2017.73.7999. Epub 2017 Dec 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2006
Primary Completion (Actual)
December 31, 2014
Study Completion (Actual)
March 31, 2026
Study Registration Dates
First Submitted
July 13, 2006
First Submitted That Met QC Criteria
July 13, 2006
First Posted (Estimated)
July 14, 2006
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genetic Diseases, Inborn
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Kidney Neoplasms
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Wilms Tumor
- Peptides
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Physical Phenomena
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glycosides
- Indoles
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Vinca Alkaloids
- Secologanin Tryptamine Alkaloids
- Indole Alkaloids
- Indolizidines
- Indolizines
- Anthracyclines
- Naphthacenes
- Aminoglycosides
- Electromagnetic Phenomena
- Magnetic Phenomena
- Radiotherapy
- Macrocyclic Compounds
- Daunorubicin
- Peptides, Cyclic
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Radiation, Nonionizing
- Radiotherapy, Computer-Assisted
- Heterocyclic Compounds, 3-Ring
- Ultrasonic Waves
- Sound
- Doxorubicin
- Vincristine
- Dactinomycin
- Specimen Handling
- Magnetic Resonance Spectroscopy
- X-Rays
- Radiotherapy, Conformal
- High-Energy Shock Waves
Other Study ID Numbers
- AREN0532 (Other Identifier: CTEP)
- U10CA180886 (U.S. NIH Grant/Contract)
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2009-01067 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000487540 (ClinicalTrials.gov)
- 06-936
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.