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Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dactinomycin

filgrastim

cyclophosphamide

doxorubicin hydrochloride

etoposide

vincristine sulfate

conventional surgery

radiation therapy

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, clear cell sarcoma of the kidney

Eligibility Criteria

0 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham Comprehensive Cancer Center
University of South Alabama Medical Center
Phoenix Children's Hospital
Arizona Cancer Center
University of Arkansas for Medical Sciences
Southern California Permanente Medical Group
City of Hope Comprehensive Cancer Center
Rebecca and John Moores UCSD Cancer Center
Loma Linda University Medical Center
Jonathan Jaques Children's Cancer Center
Children's Hospital Los Angeles
Cedars-Sinai Medical Center
Jonsson Comprehensive Cancer Center, UCLA
Children's Hospital Central California
Children's Hospital of Oakland
Chao Family Comprehensive Cancer Center
Children's Hospital of Orange County
Lucile Packard Children's Hospital at Stanford
Sutter Cancer Center
University of California Davis Medical Center
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
Children's Hospital San Diego
Kaiser Permanente Medical Center - San Francisco Geary Campus
UCSF Comprehensive Cancer Center
Santa Barbara Cottage Hospital
Kaiser Permanente Medical Center - Santa Clara
David Grant Medical Center
Children's Hospital of Denver
Childhood Hematology/Oncology Associates
Presbyterian-St Luke's Medical Center
University of Connecticut Health Center
Yale Comprehensive Cancer Center
Alfred I. Dupont Institute
Lombardi Cancer Center
Children's National Medical Center
Walter Reed Army Medical Center
Broward General Medical Center
Children's Hospital of Southwest Florida
Shands Hospital and Clinics, University of Florida
Joe DiMaggio Children's Hospital at Memorial
Nemours Children's Clinic
University of Miami-Jackson Memorial Hospital
Miami Children's Hospital
Baptist Hospital of Miami
Florida Hospital Cancer Institute
Nemours Children's Clinic-Orlando
Sacred Heart Children's Hospital
All Children's Hospital
Tampa Children's Hospital
St. Mary's Hospital
Emory University Hospital - Atlanta
Children's Healthcare of Atlanta - Scottish Rite
Medical College of Georgia Comprehensive Cancer Center
Medical Center of Central Georgia
Memorial Health University Medical Center, Inc.
Cancer Research Center of Hawaii
MBCCOP - Hawaii
Tripler Army Medical Center
Mountain States Tumor Institute
University of Chicago Cancer Research Center
Rush-Presbyterian-St. Luke's Medical Center
University of Illinois at Chicago
Children's Memorial Hospital - Chicago
Hope Children's Hospital
Lutheran General Hospital
Saint Jude Midwest Affiliate
Southern Illinois University School of Medicine
Indiana University Cancer Center
St. Vincent Hospital and Health Care Center
Raymond Blank Memorial Hospital for Children
John Stoddard Cancer Center
Holden Comprehensive Cancer Center
Wesley Medical Center
Albert B. Chandler Medical Center, University of Kentucky
Kosair Children's Hospital
Tulane University School of Medicine
Children's Hospital of New Orleans
Ochsner Clinic
Eastern Maine Medical Center
Maine Children's Cancer Program
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Sinai Hospital of Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Floating Hospital for Children
Dana-Farber Cancer Institute
Baystate Medical Center
University of Massachusetts Memorial Medical Center - University Campus
Mott Children's Hospital
Children's Hospital of Michigan
Henry Ford Hospital
St. John Hospital and Medical Center
Michigan State University
Hurley Medical Center
Spectrum Health and DeVos Children's Hospital
Bronson Methodist Hospital
CCOP - Beaumont
William Beaumont Hospital
St. Mary's/Duluth Clinic Cancer Center
Children's Hospitals and Clinics - Minneapolis
Mayo Clinic Cancer Center
Children's Hospitals and Clinics of Minnesota
University of Mississippi Medical Center
Children's Mercy Hospital
Cardinal Glennon Children's Hospital
St. Louis Children's Hospital
Children's Hospital of Omaha
University of Nebraska Medical Center
Sunrise Hospital and Medical Center
Norris Cotton Cancer Center
Hackensack University Medical Center
Cancer Institute of New Jersey
Newark Beth Israel Medical Center
St. Joseph's Hospital and Medical Center
Atlantic Health System
University of New Mexico Cancer Research and Treatment Center
Cancer Center of Albany Medical Center
Albert Einstein Clinical Cancer Center
Brooklyn Hospital Center
State University of New York Health Science Center at Brooklyn College of Medicine
Brookdale University Hospital and Medical Center
Maimonides Medical Center
Roswell Park Cancer Institute
North Shore University Hospital
Schneider Children's Hospital
New York Presbyterian Hospital - Cornell Campus
Memorial Sloan-Kettering Cancer Center
Mount Sinai School of Medicine
Columbia Presbyterian Hospital
James P. Wilmot Cancer Center
State University of New York Health Sciences Center - Stony Brook
State University of New York - Upstate Medical University
New York Medical College
Mission Saint Joseph's Health System
Lineberger Comprehensive Cancer Center, UNC
Carolinas Medical Center
Presbyterian Healthcare
Duke Comprehensive Cancer Center
East Carolina University School of Medicine
Comprehensive Cancer Center at Wake Forest University
Dakota Cancer Institute
Children's Hospital Medical Center of Akron
Children's Hospital Medical Center - Cincinnati
Ireland Cancer Center
Cleveland Clinic Taussig Cancer Center
Children's Hospital of Columbus
Children's Medical Center - Dayton
Toledo Children's Hospital
St. Vincent Mercy Medical Center
Forum Health-Tod Childrens Hospital
Children's Hospital of Oklahoma
CCOP - Oklahoma
Natalie Warren Bryant Cancer Center
Doernbecher Children's Hospital
Legacy Emanuel Hospital and Health Center
Geisinger Medical Center
Milton S. Hershey Medical Center
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Children's Hospital of Pittsburgh
Rhode Island Hospital
Medical University of South Carolina
Palmetto Health South Carolina Cancer Center
Children's Hospital of Greenville Hospital System
Avera Cancer Institute
Sioux Valley Hospital
East Tennessee State University Cancer Center at JCMC
East Tennessee Children's Hospital
Saint Jude Children's Research Hospital
Vanderbilt-Ingram Cancer Center
Texas Tech University Health Sciences Center School of Medicine
Children's Hospital of Austin
Medical City Dallas Hospital
Simmons Cancer Center - Dallas
Cook Children's Medical Center - Fort Worth
University of Texas Medical Branch
University of Texas - MD Anderson Cancer Center
Baylor College of Medicine
San Antonio Military Pediatric Cancer and Blood Disorders Center
Covenant Children's Hospital
University of Texas Health Science Center at San Antonio
Methodist Health Care System
Scott and White Memorial Hospital
Huntsman Cancer Institute
Vermont Cancer Center
Cancer Center at the University of Virginia
Inova Fairfax Hospital
Children's Hospital of the King's Daughters
Naval Medical Center, Portsmouth
Massey Cancer Center
Carilion Medical Center for Children
Children's Hospital and Regional Medical Center - Seattle
Fred Hutchinson Cancer Research Center
Group Health Cooperative
Deaconess Medical Center
Mary Bridge Children's Health Center
Madigan Army Medical Center
West Virginia University - Charleston
Cabell-Huntington Hospital, Inc
West Virginia University Hospitals
Bellin Memorial Hospital
CCOP - St. Vincent Hospital Cancer Center, Green Bay
St. Vincent Hospital
Gundersen Lutheran Medical Center
University of Wisconsin Hospital and Clinics
Marshfield Clinic
Midwest Children's Cancer Center
Sydney Children's Hospital
Children's Hospital at Westmead
Royal Children's Hospital
Women's and Children's Hospital
Royal Children's Hospital
Princess Margaret Hospital for Children
Alberta Children's Hospital
Cross Cancer Institute
British Columbia Children's Hospital
CancerCare Manitoba
Janeway Children's Health and Rehabilitation Centre
IWK Health Centre
Children's Hospital
Children's Hospital of Western Ontario
Children's Hospital of Eastern Ontario
Hospital for Sick Children
McGill University Health Center - Montreal Children's Hospital
Hopital Sainte Justine
Centre Hospitalier de L'Universite Laval
Laval University Medical Center
Allan Blair Cancer Centre
Saskatoon Cancer Centre
Academisch Ziekenhuis Groningen
Starship Children's Hospital
University of Puerto Rico School of Medicine Medical Sciences Campus
San Jorge Childrens Hospital
Swiss Pediatric Oncology Group Bern
Swiss Pediatric Oncology Group Geneva
Swiss Pediatric Oncology Group Lausanne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Arm Label

Stratum 1

Stratum 2

Stratum 3

Stratum 4

Stratum 5

Stratum 6

Stratum 7

Stratum 8

Stratum 9

Arm Description

Stage I favorable histology (FH) Wilms' tumor, under 24 months of age, and tumor weight less than 550 g: After conventional surgery (nephrectomy), patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.

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 regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.

Stage II FH Wilms' tumor: Patients receive regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate (VCR) IV weekly on weeks 1-10, 12, 15, and 18.

Stage III FH Wilms' tumor; stage II or III FA Wilms' tumor: After conventional surgery (nephrectomy), patients receive regimen DD-4A comprising dactinomycin DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weekly on weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiation therapy.

Stage IV FH or FA Wilms' tumor: patients receive regimen DD-4A comprising dactinomycin DACT IV weekly on weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weekly on weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiation therapy, and whole lung radiation therapy (at the discretion of the investigator).

Stage V FH, FA, or DA Wilms' tumor: After bilateral conventional surgery (biopsy), patients with FH receive chemotherapy as in stratum 1 (dactinomycin IV weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine sulfate IV weeks 1-10, 12, 15, and 18) or 4 (dactinomycin IV weeks 0, 6, 12, 18, and 24; doxorubicin hydrochloride IV weeks 3, 9, 15, and 21; and vincristine sulfate VCR IV weeks 1-10, 12, 15, 18, 21, and 24). Patients with FA or DA receive chemotherapy as in stratum 7 (vincristine sulfate VCR IV weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (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 hydrochloride IV (beginning after CTX infusion) 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.

Stages I-IV clear cell sarcoma): After conventional surgery (nephrectomy), patients receive vincristine sulfate VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (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 hydrochloride 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).

Stages II-IV DA Wilms' tumor: After conventional surgery (nephrectomy), Patients receive treatment as in stratum 7 (patients receive vincristine sulfate VCR IV weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide sulfate (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 hydrochloride 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).

Stages I-IV rhabdoid tumor: After conventional surgery (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. Filgrastim G-CSF is administered as on stratum 7. Patients also undergo radiation therapy. After completion of chemotherapy, patients undergo second-look conventional surgery (laparotomy) and conventional surgery (partial nephrectomy or wedge excision if feasible). After conventional surgery (second-look surgery), patients without persistent or residual disease resume chemotherapy.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00002611

First Posted

November 1, 1999

Last Updated

February 23, 2021

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00002611

Brief Title

Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

Official Title

NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 1995 (undefined)

Primary Completion Date

June 2002 (Actual)

Study Completion Date

August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, clear cell sarcoma of the kidney

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

3031 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stratum 1

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 2

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 3

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 4

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 5

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 6

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 7

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 8

Arm Type

Active Comparator

Arm Description

Arm Title

Stratum 9

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

dactinomycin

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Other Intervention Name(s)

NSC #123127, (Adriamycin)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Progression free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel M. Green, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

University of Alabama at Birmingham Comprehensive Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

University of South Alabama Medical Center

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Phoenix Children's Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016-7710

Country

United States

Facility Name

Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Southern California Permanente Medical Group

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

Rebecca and John Moores UCSD Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0658

Country

United States

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Jonathan Jaques Children's Cancer Center

City

Long Beach

State/Province

California

ZIP/Postal Code

90801-1428

Country

United States

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027-0700

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Jonsson Comprehensive Cancer Center, UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1781

Country

United States

Facility Name

Children's Hospital Central California

City

Madera

State/Province

California

ZIP/Postal Code

93638-8762

Country

United States

Facility Name

Children's Hospital of Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94609-1809

Country

United States

Facility Name

Chao Family Comprehensive Cancer Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Children's Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Lucile Packard Children's Hospital at Stanford

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Sutter Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

University of California Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Children's Hospital San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123-4282

Country

United States

Facility Name

Kaiser Permanente Medical Center - San Francisco Geary Campus

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

UCSF Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-0128

Country

United States

Facility Name

Santa Barbara Cottage Hospital

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93102

Country

United States

Facility Name

Kaiser Permanente Medical Center - Santa Clara

City

Santa Clara

State/Province

California

ZIP/Postal Code

95051-5386

Country

United States

Facility Name

David Grant Medical Center

City

Travis Air Force Base

State/Province

California

ZIP/Postal Code

94535

Country

United States

Facility Name

Children's Hospital of Denver

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218-1088

Country

United States

Facility Name

Childhood Hematology/Oncology Associates

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Presbyterian-St Luke's Medical Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06360-7106

Country

United States

Facility Name

Yale Comprehensive Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8028

Country

United States

Facility Name

Alfred I. Dupont Institute

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19899

Country

United States

Facility Name

Lombardi Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010-2970

Country

United States

Facility Name

Walter Reed Army Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20307-5000

Country

United States

Facility Name

Broward General Medical Center

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Children's Hospital of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33908

Country

United States

Facility Name

Shands Hospital and Clinics, University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610-100277

Country

United States

Facility Name

Joe DiMaggio Children's Hospital at Memorial

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Nemours Children's Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

University of Miami-Jackson Memorial Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Miami Children's Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155-4069

Country

United States

Facility Name

Baptist Hospital of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33176-2197

Country

United States

Facility Name

Florida Hospital Cancer Institute

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Nemours Children's Clinic-Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Sacred Heart Children's Hospital

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

All Children's Hospital

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Tampa Children's Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33677-4227

Country

United States

Facility Name

St. Mary's Hospital

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Emory University Hospital - Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Children's Healthcare of Atlanta - Scottish Rite

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Medical College of Georgia Comprehensive Cancer Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912-4000

Country

United States

Facility Name

Medical Center of Central Georgia

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Memorial Health University Medical Center, Inc.

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31403-3089

Country

United States

Facility Name

Cancer Research Center of Hawaii

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

MBCCOP - Hawaii

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Tripler Army Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96859-5000

Country

United States

Facility Name

Mountain States Tumor Institute

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

University of Chicago Cancer Research Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60601

Country

United States

Facility Name

Rush-Presbyterian-St. Luke's Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Children's Memorial Hospital - Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Hope Children's Hospital

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Lutheran General Hospital

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068-1174

Country

United States

Facility Name

Saint Jude Midwest Affiliate

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61637

Country

United States

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62794-9658

Country

United States

Facility Name

Indiana University Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5289

Country

United States

Facility Name

St. Vincent Hospital and Health Care Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Raymond Blank Memorial Hospital for Children

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50308

Country

United States

Facility Name

John Stoddard Cancer Center

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Holden Comprehensive Cancer Center

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242-1009

Country

United States

Facility Name

Wesley Medical Center

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Albert B. Chandler Medical Center, University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0284

Country

United States

Facility Name

Kosair Children's Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202-3830

Country

United States

Facility Name

Tulane University School of Medicine

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Children's Hospital of New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Name

Ochsner Clinic

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

Eastern Maine Medical Center

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Maine Children's Cancer Program

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201-1595

Country

United States

Facility Name

Sinai Hospital of Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21225

Country

United States

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231-2410

Country

United States

Facility Name

Floating Hospital for Children

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01107

Country

United States

Facility Name

University of Massachusetts Memorial Medical Center - University Campus

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Mott Children's Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0914

Country

United States

Facility Name

Children's Hospital of Michigan

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

St. John Hospital and Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Michigan State University

City

East Lansing

State/Province

Michigan

ZIP/Postal Code

48824

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Spectrum Health and DeVos Children's Hospital

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Bronson Methodist Hospital

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

CCOP - Beaumont

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073-6769

Country

United States

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073-6769

Country

United States

Facility Name

St. Mary's/Duluth Clinic Cancer Center

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805-1983

Country

United States

Facility Name

Children's Hospitals and Clinics - Minneapolis

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Mayo Clinic Cancer Center

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Children's Hospitals and Clinics of Minnesota

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216-4505

Country

United States

Facility Name

Children's Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Cardinal Glennon Children's Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

St. Louis Children's Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Children's Hospital of Omaha

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-2168

Country

United States

Facility Name

Sunrise Hospital and Medical Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109-2306

Country

United States

Facility Name

Norris Cotton Cancer Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0002

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Newark Beth Israel Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07112-2094

Country

United States

Facility Name

St. Joseph's Hospital and Medical Center

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07503

Country

United States

Facility Name

Atlantic Health System

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

University of New Mexico Cancer Research and Treatment Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Cancer Center of Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Albert Einstein Clinical Cancer Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Brooklyn Hospital Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

State University of New York Health Science Center at Brooklyn College of Medicine

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

Brookdale University Hospital and Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11212

Country

United States

Facility Name

Maimonides Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

Facility Name

North Shore University Hospital

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Schneider Children's Hospital

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

New York Presbyterian Hospital - Cornell Campus

City

New York

State/Province

New York

ZIP/Postal Code

10021-4885

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

James P. Wilmot Cancer Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

State University of New York Health Sciences Center - Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790-7775

Country

United States

Facility Name

State University of New York - Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

Mission Saint Joseph's Health System

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Lineberger Comprehensive Cancer Center, UNC

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7295

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28232-2861

Country

United States

Facility Name

Presbyterian Healthcare

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28233-3549

Country

United States

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

East Carolina University School of Medicine

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27858-4354

Country

United States

Facility Name

Comprehensive Cancer Center at Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1081

Country

United States

Facility Name

Dakota Cancer Institute

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103-4940

Country

United States

Facility Name

Children's Hospital Medical Center of Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Name

Children's Hospital Medical Center - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229-3039

Country

United States

Facility Name

Ireland Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

Facility Name

Cleveland Clinic Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Children's Hospital of Columbus

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205-2696

Country

United States

Facility Name

Children's Medical Center - Dayton

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

Toledo Children's Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43601

Country

United States

Facility Name

St. Vincent Mercy Medical Center

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Forum Health-Tod Childrens Hospital

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44501

Country

United States

Facility Name

Children's Hospital of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

CCOP - Oklahoma

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Natalie Warren Bryant Cancer Center

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Doernbecher Children's Hospital

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201-3098

Country

United States

Facility Name

Legacy Emanuel Hospital and Health Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Geisinger Medical Center

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822-1320

Country

United States

Facility Name

Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

St. Christopher's Hospital for Children

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134-1095

Country

United States

Facility Name

Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02818

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425-0721

Country

United States

Facility Name

Palmetto Health South Carolina Cancer Center

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

Children's Hospital of Greenville Hospital System

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105-1080

Country

United States

Facility Name

Sioux Valley Hospital

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57117

Country

United States

Facility Name

East Tennessee State University Cancer Center at JCMC

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Facility Name

East Tennessee Children's Hospital

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37901

Country

United States

Facility Name

Saint Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105-2794

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

Facility Name

Texas Tech University Health Sciences Center School of Medicine

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Children's Hospital of Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78701

Country

United States

Facility Name

Medical City Dallas Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Simmons Cancer Center - Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235-9154

Country

United States

Facility Name

Cook Children's Medical Center - Fort Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0361

Country

United States

Facility Name

University of Texas - MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

San Antonio Military Pediatric Cancer and Blood Disorders Center

City

Lackland Air Force Base

State/Province

Texas

ZIP/Postal Code

78236-5300

Country

United States

Facility Name

Covenant Children's Hospital

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

Methodist Health Care System

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3902

Country

United States

Facility Name

Scott and White Memorial Hospital

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Vermont Cancer Center

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401-3498

Country

United States

Facility Name

Cancer Center at the University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Inova Fairfax Hospital

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042-3300

Country

United States

Facility Name

Children's Hospital of the King's Daughters

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Naval Medical Center, Portsmouth

City

Portsmouth

State/Province

Virginia

ZIP/Postal Code

23708-5100

Country

United States

Facility Name

Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0037

Country

United States

Facility Name

Carilion Medical Center for Children

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24013

Country

United States

Facility Name

Children's Hospital and Regional Medical Center - Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-1024

Country

United States

Facility Name

Group Health Cooperative

City

Seattle

State/Province

Washington

ZIP/Postal Code

98112

Country

United States

Facility Name

Deaconess Medical Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99210-0248

Country

United States

Facility Name

Mary Bridge Children's Health Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98415-0299

Country

United States

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431-5000

Country

United States

Facility Name

West Virginia University - Charleston

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25302

Country

United States

Facility Name

Cabell-Huntington Hospital, Inc

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25701

Country

United States

Facility Name

West Virginia University Hospitals

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9300

Country

United States

Facility Name

Bellin Memorial Hospital

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54301

Country

United States

Facility Name

CCOP - St. Vincent Hospital Cancer Center, Green Bay

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54301

Country

United States

Facility Name

St. Vincent Hospital

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54307-9070

Country

United States

Facility Name

Gundersen Lutheran Medical Center

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-0001

Country

United States

Facility Name

Marshfield Clinic

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449-5772

Country

United States

Facility Name

Midwest Children's Cancer Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Sydney Children's Hospital

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Children's Hospital at Westmead

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Children's Hospital

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Women's and Children's Hospital

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Princess Margaret Hospital for Children

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6001

Country

Australia

Facility Name

Alberta Children's Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2T 5C7

Country

Canada

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

British Columbia Children's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

Facility Name

CancerCare Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Janeway Children's Health and Rehabilitation Centre

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3J 3G9

Country

Canada

Facility Name

Children's Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Children's Hospital of Western Ontario

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 2V5

Country

Canada

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Facility Name

McGill University Health Center - Montreal Children's Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1P3

Country

Canada

Facility Name

Hopital Sainte Justine

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Centre Hospitalier de L'Universite Laval

City

Sainte Foy

State/Province

Quebec

ZIP/Postal Code

GIV 4G2

Country

Canada

Facility Name

Laval University Medical Center

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Allan Blair Cancer Centre

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Saskatoon Cancer Centre

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Academisch Ziekenhuis Groningen

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

Facility Name

Starship Children's Hospital

City

Auckland

Country

New Zealand

Facility Name

University of Puerto Rico School of Medicine Medical Sciences Campus

City

San Juan

ZIP/Postal Code

00936-5067

Country

Puerto Rico

Facility Name

San Jorge Childrens Hospital

City

Santurce

ZIP/Postal Code

00912

Country

Puerto Rico

Facility Name

Swiss Pediatric Oncology Group Bern

City

Bern

ZIP/Postal Code

CH 3010

Country

Switzerland

Facility Name

Swiss Pediatric Oncology Group Geneva

City

Geneva

ZIP/Postal Code

CH 1211

Country

Switzerland

Facility Name

Swiss Pediatric Oncology Group Lausanne

City

Lausanne

ZIP/Postal Code

CH 1011

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

22422736

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.

Results Reference

background

PubMed Identifier

22498384

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.

Results Reference

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PubMed Identifier

21683387

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.

Results Reference

background

PubMed Identifier

20457352

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.

Results Reference

background

PubMed Identifier

19730241

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.

Results Reference

background

PubMed Identifier

18778996

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.

Results Reference

background

PubMed Identifier

18095319

Citation

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. doi: 10.1002/pbc.21389.

Results Reference

background

PubMed Identifier

16700047

Citation

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. doi: 10.1002/pbc.20891.

Results Reference

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PubMed Identifier

15590168

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. doi: 10.1016/j.ijrobp.2004.05.057.

Results Reference

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PubMed Identifier

22952427

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 Oncology Group Study. Neoplasia. 2012 Aug;14(8):742-56. doi: 10.1593/neo.12714.

Results Reference

result

PubMed Identifier

21189373

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 study. J Clin Oncol. 2011 Feb 20;29(6):698-703. doi: 10.1200/JCO.2010.31.5192. Epub 2010 Dec 28.

Results Reference

result

PubMed Identifier

18989885

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 from the Children's Oncology Group. Pediatr Blood Cancer. 2009 Feb;52(2):254-8. doi: 10.1002/pbc.21809.

Results Reference

result

PubMed Identifier

19208794

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 Children's Oncology Group. Clin Cancer Res. 2009 Mar 1;15(5):1770-8. doi: 10.1158/1078-0432.CCR-08-1030. Epub 2009 Feb 10.

Results Reference

result

PubMed Identifier

17539021

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, Newbury R, Weeks D; National Wilms Tumor Study Group. Treatment of Wilms tumor relapsing after initial treatment with vincristine, actinomycin D, and doxorubicin. A report from the National Wilms Tumor Study Group. Pediatr Blood Cancer. 2008 Feb;50(2):236-41. doi: 10.1002/pbc.21267.

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PubMed Identifier

16710034

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' tumor: results from the fifth National Wilms' Tumor Study. J Clin Oncol. 2006 May 20;24(15):2352-8. doi: 10.1200/JCO.2005.04.7852.

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16410127

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 National Wilms' Tumor Study Group (National Wilms' Tumor Study 5). J Pediatr Surg. 2006 Jan;41(1):162-7; discussion 162-7. doi: 10.1016/j.jpedsurg.2005.10.020.

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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.

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16172460

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. doi: 10.1200/JCO.2005.00.562. Epub 2005 Sep 19.

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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 212-3. doi: 10.1016/j.jpedsurg.2004.09.044.

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PubMed Identifier

16129848

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 heterozygosity for chromosomes 1p and 16q is an adverse prognostic factor in favorable-histology Wilms tumor: a report from the National Wilms Tumor Study Group. J Clin Oncol. 2005 Oct 10;23(29):7312-21. doi: 10.1200/JCO.2005.01.2799. Epub 2005 Aug 29.

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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. doi: 10.1097/01.mph.0000149961.71266.27.

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Links:

URL

https://nctn-data-archive.nci.nih.gov/

Description

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Learn more about this trial

Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

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