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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002611
Other study ID # 9440
Secondary ID COG-Q9401NWTS-Q9
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1995
Est. completion date August 2003

Study information

Verified date July 2014
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.


Description:

OBJECTIVES: - Increase survival rate of children with favorable histology (FH) Wilms' tumor and other childhood renal tumors. - Determine whether loss of heterozygosity for chromosome 16q or 1p in tumor tissue is associated with a poorer prognosis in children with FH Wilms' tumor. - Determine whether increased DNA content in tumor cells is associated with a poorer prognosis in children with FH Wilms' tumor. - Decrease the acute and long-term morbidity in children with Wilms' tumor by limiting initial therapy and consistently using the same regimen (protocol NWTS-5/R) for patients who relapse following initial treatment. - Improve overall and disease-free survival of patients with renal tumors of unfavorable histology, including Wilms' tumor with diffuse anaplasia and clear cell sarcoma of the kidney, using a new treatment regimen that includes etoposide (VP-16) and cyclophosphamide (CTX). - Improve overall and disease-free survival in patients with malignant rhabdoid tumor of the kidney using a new treatment regimen that includes carboplatin, VP-16, and CTX. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001) - Provide data regarding loss of heterozygosity for chromosomes 11p15, 16q, and 1p, age at diagnosis, precursor lesions (perilobar, intralobar, nephroblastomatosis), bilaterality, and presence of congenital anomalies required for the completion of protocol A0026 (a case-control study of risk factors for Wilms' tumor). OUTLINE: This is a multicenter study. Patients are assigned to one of nine strata based on tumor histology, stage, tumor weight, and age. - Stratum 1 (stage I favorable histology (FH) Wilms' tumor, under 24 months of age, and tumor weight less than 550 g): After nephrectomy, patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine (VCR) IV weekly on weeks 1-10, 12, 15, and 18. - Stratum 2 (stage I FH Wilms' tumor and age 24 months and over or tumor weight at least 550 g; stage I focal anaplastic (FA) or diffuse anaplastic (DA) Wilms' tumor): Patients receive therapy as in stratum 1. - Stratum 3 (stage II FH Wilms' tumor): Patients receive therapy as in stratum 1. - Stratum 4 (stage III FH Wilms' tumor; stage II or III FA Wilms' tumor): After nephrectomy, patients receive regimen DD-4A comprising DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin IV weekly on weeks 3, 9, 15, and 21; and VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiotherapy. - Stratum 5 (stage IV FH or FA Wilms' tumor): Patients receive chemotherapy as in stratum 4, abdominal radiotherapy, and whole lung radiotherapy (at the discretion of the investigator). - Stratum 6 (stage V FH, FA, or DA Wilms' tumor ): After bilateral biopsy, patients with FH receive chemotherapy as in stratum 1 or 4. Patients with FA or DA receive chemotherapy as in stratum 7. - Stratum 7 (stages I-IV clear cell sarcoma): After nephrectomy, patients receive VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide (CTX) IV over 1 hour on days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21; doxorubicin IV (beginning after CTX infusion) weekly on weeks 0, 6, 12, 18, and 24; and etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Patients also undergo abdominal radiotherapy and whole lung radiotherapy (if pulmonary metastases are present). - Stratum 8 (stages II-IV DA Wilms' tumor): Patients receive treatment as in stratum 7. - Stratum 9 (stages I-IV rhabdoid tumor): After nephrectomy, patients receive carboplatin IV on days 1-2 and VP-16 IV over 1 hour (beginning after carboplatin infusion) on days 1-3 of weeks 0, 3, 9, 12, 18, and 21 and CTX IV over 1 hour on days 1-5 of weeks 6, 15, and 24. G-CSF is administered as in stratum 7. Patients also undergo radiotherapy. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001.) After completion of chemotherapy, patients undergo second-look laparotomy and partial nephrectomy or wedge excision (if feasible). After second-look surgery, patients without persistent or residual disease resume chemotherapy. Patients are followed every 3 months for 5 years, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 207 patients will be accrued for the treatment portion of this study. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001.)


Recruitment information / eligibility

Status Completed
Enrollment 3031
Est. completion date August 2003
Est. primary completion date June 2002
Accepts healthy volunteers No
Gender All
Age group N/A to 15 Years
Eligibility DISEASE CHARACTERISTICS: - Histologically confirmed stage I-V kidney cancer of one of the following histologies: - Wilms' tumor, favorable histology - Wilms' tumor, focal or diffuse anaplastic - Clear cell sarcoma - Rhabdoid tumor - (The rhabdoid tumor stratum closed to accrual effective 07/13/2001) - Prior nephrectomy or biopsy required - Prior bilateral biopsy (preferably open) with bilateral staging and pathologic evaluation required for bilateral tumor - Must begin study therapy within 5 days after nephrectomy (unless medically contraindicated) PATIENT CHARACTERISTICS: Age: - Under 16 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics

Study Design


Intervention

Biological:
dactinomycin

filgrastim

Drug:
cyclophosphamide

doxorubicin hydrochloride
Source and Pharmacology: An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Binds to DNA and inhibits nucleic acid synthesis, with its major lethal effect occurring during the S phase of the cell cycle. Has some topoisomerase II inhibitory activity. Since it is primarily excreted by the liver, any liver impairment may enhance toxicity. 40% to 50% is excreted in the bile; <5% in the urine. The drug has a very short initial t½ of <20 minutes and a terminal t½ of 17 hours. Animal studies indicate cytotoxic levels persist in tissue for as long as 24 hours.
etoposide

vincristine sulfate

Procedure:
conventional surgery

Radiation:
radiation therapy


Locations

Country Name City State
Australia Royal Children's Hospital Brisbane Queensland
Australia Women's and Children's Hospital North Adelaide South Australia
Australia Royal Children's Hospital Parkville Victoria
Australia Princess Margaret Hospital for Children Perth Western Australia
Australia Sydney Children's Hospital Randwick New South Wales
Australia Children's Hospital at Westmead Westmead New South Wales
Canada Alberta Children's Hospital Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada Children's Hospital Hamilton Ontario
Canada Children's Hospital of Western Ontario London Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada McGill University Health Center - Montreal Children's Hospital Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Centre Hospitalier de L'Universite Laval Sainte Foy Quebec
Canada Laval University Medical Center Sainte-Foy Quebec
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Janeway Children's Health and Rehabilitation Centre St. John's Newfoundland and Labrador
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Netherlands Academisch Ziekenhuis Groningen Groningen
New Zealand Starship Children's Hospital Auckland
Puerto Rico University of Puerto Rico School of Medicine Medical Sciences Campus San Juan
Puerto Rico San Jorge Childrens Hospital Santurce
Switzerland Swiss Pediatric Oncology Group Bern Bern
Switzerland Swiss Pediatric Oncology Group Geneva Geneva
Switzerland Swiss Pediatric Oncology Group Lausanne Lausanne
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Cancer Center of Albany Medical Center Albany New York
United States University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico
United States Texas Tech University Health Sciences Center School of Medicine Amarillo Texas
United States Mott Children's Hospital Ann Arbor Michigan
United States Mission Saint Joseph's Health System Asheville North Carolina
United States Children's Healthcare of Atlanta - Scottish Rite Atlanta Georgia
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Medical College of Georgia Comprehensive Cancer Center Augusta Georgia
United States Children's Hospital of Austin Austin Texas
United States Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Mountain States Tumor Institute Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Floating Hospital for Children Boston Massachusetts
United States Albert Einstein Clinical Cancer Center Bronx New York
United States Brookdale University Hospital and Medical Center Brooklyn New York
United States Brooklyn Hospital Center Brooklyn New York
United States Maimonides Medical Center Brooklyn New York
United States State University of New York Health Science Center at Brooklyn College of Medicine Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University - Charleston Charleston West Virginia
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Healthcare Charlotte North Carolina
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Children's Memorial Hospital - Chicago Chicago Illinois
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Palmetto Health South Carolina Cancer Center Columbia South Carolina
United States Children's Hospital of Columbus Columbus Ohio
United States Medical City Dallas Hospital Dallas Texas
United States Simmons Cancer Center - Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Children's Medical Center - Dayton Dayton Ohio
United States Childhood Hematology/Oncology Associates Denver Colorado
United States Children's Hospital of Denver Denver Colorado
United States Presbyterian-St Luke's Medical Center Denver Colorado
United States John Stoddard Cancer Center Des Moines Iowa
United States Raymond Blank Memorial Hospital for Children Des Moines Iowa
United States Children's Hospital of Michigan Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States St. John Hospital and Medical Center Detroit Michigan
United States Southern California Permanente Medical Group Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States St. Mary's/Duluth Clinic Cancer Center Duluth Minnesota
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Michigan State University East Lansing Michigan
United States Inova Fairfax Hospital Falls Church Virginia
United States Dakota Cancer Institute Fargo North Dakota
United States University of Connecticut Health Center Farmington Connecticut
United States Hurley Medical Center Flint Michigan
United States Broward General Medical Center Fort Lauderdale Florida
United States Children's Hospital of Southwest Florida Fort Myers Florida
United States Cook Children's Medical Center - Fort Worth Fort Worth Texas
United States Shands Hospital and Clinics, University of Florida Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States Spectrum Health and DeVos Children's Hospital Grand Rapids Michigan
United States Bellin Memorial Hospital Green Bay Wisconsin
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Green Bay Wisconsin
United States Children's Hospital of Greenville Hospital System Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States Joe DiMaggio Children's Hospital at Memorial Hollywood Florida
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States MBCCOP - Hawaii Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Cabell-Huntington Hospital, Inc Huntington West Virginia
United States Indiana University Cancer Center Indianapolis Indiana
United States St. Vincent Hospital and Health Care Center Indianapolis Indiana
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States East Tennessee State University Cancer Center at JCMC Johnson City Tennessee
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Children's Mercy Hospital Kansas City Missouri
United States East Tennessee Children's Hospital Knoxville Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Loma Linda University Medical Center Loma Linda California
United States Jonathan Jaques Children's Cancer Center Long Beach California
United States Cedars-Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Medical Center of Central Georgia Macon Georgia
United States Children's Hospital Central California Madera California
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States North Shore University Hospital Manhasset New York
United States Marshfield Clinic Marshfield Wisconsin
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Baptist Hospital of Miami Miami Florida
United States Miami Children's Hospital Miami Florida
United States University of Miami-Jackson Memorial Hospital Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States Children's Hospitals and Clinics - Minneapolis Minneapolis Minnesota
United States University of South Alabama Medical Center Mobile Alabama
United States West Virginia University Hospitals Morgantown West Virginia
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Schneider Children's Hospital New Hyde Park New York
United States Children's Hospital of New Orleans New Orleans Louisiana
United States Ochsner Clinic New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Columbia Presbyterian Hospital New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai School of Medicine New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Children's Hospital of the King's Daughters Norfolk Virginia
United States Hope Children's Hospital Oak Lawn Illinois
United States Children's Hospital of Oakland Oakland California
United States Children's Hospital of Oklahoma Oklahoma City Oklahoma
United States Children's Hospital of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Chao Family Comprehensive Cancer Center Orange California
United States Children's Hospital of Orange County Orange California
United States Florida Hospital Cancer Institute Orlando Florida
United States Nemours Children's Clinic-Orlando Orlando Florida
United States Lucile Packard Children's Hospital at Stanford Palo Alto California
United States Lutheran General Hospital Park Ridge Illinois
United States St. Joseph's Hospital and Medical Center Paterson New Jersey
United States Sacred Heart Children's Hospital Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States St. Christopher's Hospital for Children Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Doernbecher Children's Hospital Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Rhode Island Hospital Providence Rhode Island
United States Massey Cancer Center Richmond Virginia
United States Carilion Medical Center for Children Roanoke Virginia
United States James P. Wilmot Cancer Center Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CCOP - Beaumont Royal Oak Michigan
United States William Beaumont Hospital Royal Oak Michigan
United States Sutter Cancer Center Sacramento California
United States University of California Davis Medical Center Sacramento California
United States Cardinal Glennon Children's Hospital Saint Louis Missouri
United States St. Louis Children's Hospital Saint Louis Missouri
United States Children's Hospitals and Clinics of Minnesota Saint Paul Minnesota
United States All Children's Hospital Saint Petersburg Florida
United States Huntsman Cancer Institute Salt Lake City Utah
United States Methodist Health Care System San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Children's Hospital San Diego San Diego California
United States Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego San Diego California
United States Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco California
United States UCSF Comprehensive Cancer Center San Francisco California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Memorial Health University Medical Center, Inc. Savannah Georgia
United States Maine Children's Cancer Program Scarborough Maine
United States Children's Hospital and Regional Medical Center - Seattle Seattle Washington
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Cooperative Seattle Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sioux Valley Hospital Sioux Falls South Dakota
United States Deaconess Medical Center Spokane Washington
United States Baystate Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States State University of New York Health Sciences Center - Stony Brook Stony Brook New York
United States Atlantic Health System Summit New Jersey
United States State University of New York - Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Mary Bridge Children's Health Center Tacoma Washington
United States Tampa Children's Hospital Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Children's Hospital Toledo Ohio
United States David Grant Medical Center Travis Air Force Base California
United States Arizona Cancer Center Tucson Arizona
United States CCOP - Oklahoma Tulsa Oklahoma
United States Natalie Warren Bryant Cancer Center Tulsa Oklahoma
United States New York Medical College Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States Lombardi Cancer Center Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States St. Mary's Hospital West Palm Beach Florida
United States Wesley Medical Center Wichita Kansas
United States Alfred I. Dupont Institute Wilmington Delaware
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts
United States Forum Health-Tod Childrens Hospital Youngstown Ohio

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  New Zealand,  Puerto Rico,  Switzerland, 

References & Publications (21)

Breslow NE, Beckwith JB, Perlman EJ, Reeve AE. Age distributions, birth weights, nephrogenic rests, and heterogeneity in the pathogenesis of Wilms tumor. Pediatr Blood Cancer. 2006 Sep;47(3):260-7. — View Citation

Dome JS, Bockhold CA, Li SM, Baker SD, Green DM, Perlman EJ, Hill DA, Breslow NE. High telomerase RNA expression level is an adverse prognostic factor for favorable-histology Wilms' tumor. J Clin Oncol. 2005 Dec 20;23(36):9138-45. Epub 2005 Sep 19. — View Citation

Dome JS, Cotton CA, Perlman EJ, Breslow NE, Kalapurakal JA, Ritchey ML, Grundy PE, Malogolowkin M, Beckwith JB, Shamberger RC, Haase GM, Coppes MJ, Coccia P, Kletzel M, Weetman RM, Donaldson M, Macklis RM, Green DM. Treatment of anaplastic histology Wilms — View Citation

Ehrlich PF, Ferrer FA, Ritchey ML, Anderson JR, Green DM, Grundy PE, Dome JS, Kalapurakal JA, Perlman EJ, Shamberger RC. Hepatic metastasis at diagnosis in patients with Wilms tumor is not an independent adverse prognostic factor for stage IV Wilms tumor: a report from the Children's Oncology Group/National Wilms Tumor Study Group. Ann Surg. 2009 Oct;250(4):642-8. doi: 10.1097/SLA.0b013e3181b76f20. — View Citation

Ehrlich PF, Hamilton TE, Grundy P, Ritchey M, Haase G, Shamberger RC; National Wilms' Tumor Study Group (National Wilms' Tumor Study 5). The value of surgery in directing therapy for patients with Wilms' tumor with pulmonary disease. A report from the Nat — View Citation

Ehrlich PF, Ritchey ML, Hamilton TE, Haase GM, Ou S, Breslow N, Grundy P, Green D, Norkool P, Becker J, Shamberger RC. Quality assessment for Wilms' tumor: a report from the National Wilms' Tumor Study-5. J Pediatr Surg. 2005 Jan;40(1):208-12; discussion — View Citation

Fernandez CV, Anderson J, Breslow NE, Dome JS, Grundy PE, Perlman EJ, Green DM; National Wilms Tumor Study Group/Children's Oncology Group. Anthropomorphic measurements and event-free survival in patients with favorable histology Wilms tumor: a report fro — View Citation

Gadd S, Huff V, Huang CC, Ruteshouser EC, Dome JS, Grundy PE, Breslow N, Jennings L, Green DM, Beckwith JB, Perlman EJ. Clinically relevant subsets identified by gene expression patterns support a revised ontogenic model of Wilms tumor: a Children's Oncol — View Citation

Grundy PE, Breslow NE, Li S, Perlman E, Beckwith JB, Ritchey ML, Shamberger RC, Haase GM, D'Angio GJ, Donaldson M, Coppes MJ, Malogolowkin M, Shearer P, Thomas PR, Macklis R, Tomlinson G, Huff V, Green DM; National Wilms Tumor Study Group. Loss of heteroz — View Citation

Grundy PE, Green DM, Dirks AC, Berendt AE, Breslow NE, Anderson JR, Dome JS. Clinical significance of pulmonary nodules detected by CT and Not CXR in patients treated for favorable histology Wilms tumor on national Wilms tumor studies-4 and -5: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Oct;59(4):631-5. doi: 10.1002/pbc.24123. Epub 2012 Mar 15. — View Citation

Huang CC, Gadd S, Breslow N, Cutcliffe C, Sredni ST, Helenowski IB, Dome JS, Grundy PE, Green DM, Fritsch MK, Perlman EJ. Predicting relapse in favorable histology Wilms tumor using gene expression analysis: a report from the Renal Tumor Committee of the — View Citation

Kalapurakal JA, Green DM, Haase G, Anderson JR, Dome JS, Grundy PE. Outcomes of children with favorable histology wilms tumor and peritoneal implants treated in National Wilms Tumor Studies-4 and -5. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):554-8. doi: 10.1016/j.ijrobp.2009.04.081. — View Citation

Kalapurakal JA, Nan B, Norkool P, Coppes M, Perlman E, Beckwith B, Ritchey M, Breslow N, Grundy P, D'angio GJ, Green DM, Thomas PR. Treatment outcomes in adults with favorable histologic type Wilms tumor-an update from the National Wilms Tumor Study Group. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1379-84. — View Citation

Kieran K, Anderson JR, Dome JS, Ehrlich PF, Ritchey ML, Shamberger RC, Perlman EJ, Green DM, Davidoff AM. Lymph node involvement in Wilms tumor: results from National Wilms Tumor Studies 4 and 5. J Pediatr Surg. 2012 Apr;47(4):700-6. doi: 10.1016/j.jpedsurg.2011.08.017. — View Citation

Lange J, Peterson SM, Takashima JR, Grigoriev Y, Ritchey ML, Shamberger RC, Beckwith JB, Perlman E, Green DM, Breslow NE. Risk factors for end stage renal disease in non-WT1-syndromic Wilms tumor. J Urol. 2011 Aug;186(2):378-86. doi: 10.1016/j.juro.2011.03.110. Epub 2011 Jun 17. — View Citation

Malogolowkin M, Cotton CA, Green DM, Breslow NE, Perlman E, Miser J, Ritchey ML, Thomas PR, Grundy PE, D'Angio GJ, Beckwith JB, Shamberger RC, Haase GM, Donaldson M, Weetman R, Coppes MJ, Shearer P, Coccia P, Kletzel M, Macklis R, Tomlinson G, Huff V, New — View Citation

Miller MA, Karacay B, Breslow NE, Li S, O'Dorisio MS, Grundy PE, Sandler AD. Prognostic value of quantifying apoptosis factor expression in favorable histology wilms tumors. J Pediatr Hematol Oncol. 2005 Jan;27(1):11-4. — View Citation

Perlman EJ, Grundy PE, Anderson JR, Jennings LJ, Green DM, Dome JS, Shamberger RC, Ruteshouser EC, Huff V. WT1 mutation and 11P15 loss of heterozygosity predict relapse in very low-risk wilms tumors treated with surgery alone: a children's oncology group — View Citation

Ritchey M, Daley S, Shamberger RC, Ehrlich P, Hamilton T, Haase G, Sawin R; National Wilms' Tumor Study Group. Ureteral extension in Wilms' tumor: a report from the National Wilms' Tumor Study Group (NWTSG). J Pediatr Surg. 2008 Sep;43(9):1625-9. doi: 10.1016/j.jpedsurg.2008.01.067. — View Citation

Seibel NL, Sun J, Anderson JR, et al.: Outcome of clear cell sarcoma of the kidney (CCSK) treated on the National Wilms Tumor Study-5 (NWTS). [Abstract] J Clin Oncol 24 (Suppl 18): A-9000, 502s, 2006.

van den Heuvel-Eibrink MM, Grundy P, Graf N, Pritchard-Jones K, Bergeron C, Patte C, van Tinteren H, Rey A, Langford C, Anderson JR, de Kraker J. Characteristics and survival of 750 children diagnosed with a renal tumor in the first seven months of life: A collaborative study by the SIOP/GPOH/SFOP, NWTSG, and UKCCSG Wilms tumor study groups. Pediatr Blood Cancer. 2008 Jun;50(6):1130-4. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival
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