Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Stratum 1 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. |
Biological: dactinomycin
Drug: vincristine sulfate
Procedure: conventional surgery
|
| Active Comparator: 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 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. |
Biological: dactinomycin
Drug: vincristine sulfate
|
| Active Comparator: Stratum 3 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. |
Biological: dactinomycin
Drug: vincristine sulfate
|
| Active Comparator: Stratum 4 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. |
Biological: dactinomycin
Drug: 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.
Other Names:
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
|
| Active Comparator: Stratum 5 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). |
Biological: dactinomycin
Drug: 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.
Other Names:
Drug: vincristine sulfate
|
| Active Comparator: Stratum 6 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. |
Biological: dactinomycin
Biological: filgrastim
Drug: cyclophosphamide
Drug: 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.
Other Names:
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
|
| Active Comparator: Stratum 7 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). |
Biological: filgrastim
Drug: 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.
Other Names:
Drug: etoposide
Procedure: conventional surgery
Radiation: radiation therapy
|
| Active Comparator: Stratum 8 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). |
Biological: filgrastim
Drug: cyclophosphamide
Drug: 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.
Other Names:
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
|
| Active Comparator: Stratum 9 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. |
Biological: filgrastim
Drug: etoposide
Procedure: conventional surgery
Radiation: radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Progression free survival []
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | United States | 35233 |
| 2 | University of South Alabama Medical Center | Mobile | Alabama | United States | 36604 |
| 3 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016-7710 |
| 4 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
| 5 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 6 | Southern California Permanente Medical Group | Downey | California | United States | 90242 |
| 7 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
| 8 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
| 9 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 10 | Jonathan Jaques Children's Cancer Center | Long Beach | California | United States | 90801-1428 |
| 11 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027-0700 |
| 12 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 13 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 14 | Children's Hospital Central California | Madera | California | United States | 93638-8762 |
| 15 | Children's Hospital of Oakland | Oakland | California | United States | 94609-1809 |
| 16 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 17 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 18 | Lucile Packard Children's Hospital at Stanford | Palo Alto | California | United States | 94304 |
| 19 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 20 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
| 21 | Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego | California | United States | 92120 |
| 22 | Children's Hospital San Diego | San Diego | California | United States | 92123-4282 |
| 23 | Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco | California | United States | 94115 |
| 24 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94143-0128 |
| 25 | Santa Barbara Cottage Hospital | Santa Barbara | California | United States | 93102 |
| 26 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051-5386 |
| 27 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 28 | Children's Hospital of Denver | Denver | Colorado | United States | 80218-1088 |
| 29 | Childhood Hematology/Oncology Associates | Denver | Colorado | United States | 80218 |
| 30 | Presbyterian-St Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 31 | University of Connecticut Health Center | Farmington | Connecticut | United States | 06360-7106 |
| 32 | Yale Comprehensive Cancer Center | New Haven | Connecticut | United States | 06520-8028 |
| 33 | Alfred I. Dupont Institute | Wilmington | Delaware | United States | 19899 |
| 34 | Lombardi Cancer Center | Washington | District of Columbia | United States | 20007 |
| 35 | Children's National Medical Center | Washington | District of Columbia | United States | 20010-2970 |
| 36 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 37 | Broward General Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 38 | Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 39 | Shands Hospital and Clinics, University of Florida | Gainesville | Florida | United States | 32610-100277 |
| 40 | Joe DiMaggio Children's Hospital at Memorial | Hollywood | Florida | United States | 33021 |
| 41 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
| 42 | University of Miami-Jackson Memorial Hospital | Miami | Florida | United States | 33136 |
| 43 | Miami Children's Hospital | Miami | Florida | United States | 33155-4069 |
| 44 | Baptist Hospital of Miami | Miami | Florida | United States | 33176-2197 |
| 45 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32803 |
| 46 | Nemours Children's Clinic-Orlando | Orlando | Florida | United States | 32806 |
| 47 | Sacred Heart Children's Hospital | Pensacola | Florida | United States | 32504 |
| 48 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 49 | Tampa Children's Hospital | Tampa | Florida | United States | 33677-4227 |
| 50 | St. Mary's Hospital | West Palm Beach | Florida | United States | 33407 |
| 51 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 52 | Children's Healthcare of Atlanta - Scottish Rite | Atlanta | Georgia | United States | 30342 |
| 53 | Medical College of Georgia Comprehensive Cancer Center | Augusta | Georgia | United States | 30912-4000 |
| 54 | Medical Center of Central Georgia | Macon | Georgia | United States | 31201 |
| 55 | Memorial Health University Medical Center, Inc. | Savannah | Georgia | United States | 31403-3089 |
| 56 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 57 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 58 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
| 59 | Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 60 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60601 |
| 61 | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | United States | 60612 |
| 62 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 63 | Children's Memorial Hospital - Chicago | Chicago | Illinois | United States | 60614 |
| 64 | Hope Children's Hospital | Oak Lawn | Illinois | United States | 60453 |
| 65 | Lutheran General Hospital | Park Ridge | Illinois | United States | 60068-1174 |
| 66 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 67 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62794-9658 |
| 68 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
| 69 | St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 70 | Raymond Blank Memorial Hospital for Children | Des Moines | Iowa | United States | 50308 |
| 71 | John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
| 72 | Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242-1009 |
| 73 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 74 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0284 |
| 75 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40202-3830 |
| 76 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 77 | Children's Hospital of New Orleans | New Orleans | Louisiana | United States | 70118 |
| 78 | Ochsner Clinic | New Orleans | Louisiana | United States | 70121 |
| 79 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 80 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074 |
| 81 | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | United States | 21201-1595 |
| 82 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21225 |
| 83 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
| 84 | Floating Hospital for Children | Boston | Massachusetts | United States | 02111 |
| 85 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 86 | Baystate Medical Center | Springfield | Massachusetts | United States | 01107 |
| 87 | University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 88 | Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109-0914 |
| 89 | Children's Hospital of Michigan | Detroit | Michigan | United States | 48201 |
| 90 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 91 | St. John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 92 | Michigan State University | East Lansing | Michigan | United States | 48824 |
| 93 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 94 | Spectrum Health and DeVos Children's Hospital | Grand Rapids | Michigan | United States | 49503 |
| 95 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 96 | CCOP - Beaumont | Royal Oak | Michigan | United States | 48073-6769 |
| 97 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073-6769 |
| 98 | St. Mary's/Duluth Clinic Cancer Center | Duluth | Minnesota | United States | 55805-1983 |
| 99 | Children's Hospitals and Clinics - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 100 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 101 | Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | United States | 55102 |
| 102 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 103 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 104 | Cardinal Glennon Children's Hospital | Saint Louis | Missouri | United States | 63104 |
| 105 | St. Louis Children's Hospital | Saint Louis | Missouri | United States | 63110 |
| 106 | Children's Hospital of Omaha | Omaha | Nebraska | United States | 68114 |
| 107 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-2168 |
| 108 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109-2306 |
| 109 | Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756-0002 |
| 110 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 111 | Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 112 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112-2094 |
| 113 | St. Joseph's Hospital and Medical Center | Paterson | New Jersey | United States | 07503 |
| 114 | Atlantic Health System | Summit | New Jersey | United States | 07901 |
| 115 | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | United States | 87131 |
| 116 | Cancer Center of Albany Medical Center | Albany | New York | United States | 12208 |
| 117 | Albert Einstein Clinical Cancer Center | Bronx | New York | United States | 10461 |
| 118 | Brooklyn Hospital Center | Brooklyn | New York | United States | 11201 |
| 119 | State University of New York Health Science Center at Brooklyn College of Medicine | Brooklyn | New York | United States | 11203 |
| 120 | Brookdale University Hospital and Medical Center | Brooklyn | New York | United States | 11212 |
| 121 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 122 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 123 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 124 | Schneider Children's Hospital | New Hyde Park | New York | United States | 11042 |
| 125 | New York Presbyterian Hospital - Cornell Campus | New York | New York | United States | 10021-4885 |
| 126 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 127 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 128 | Columbia Presbyterian Hospital | New York | New York | United States | 10032 |
| 129 | James P. Wilmot Cancer Center | Rochester | New York | United States | 14642 |
| 130 | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | United States | 11790-7775 |
| 131 | State University of New York - Upstate Medical University | Syracuse | New York | United States | 13210 |
| 132 | New York Medical College | Valhalla | New York | United States | 10595 |
| 133 | Mission Saint Joseph's Health System | Asheville | North Carolina | United States | 28801 |
| 134 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 135 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 136 | Presbyterian Healthcare | Charlotte | North Carolina | United States | 28233-3549 |
| 137 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 138 | East Carolina University School of Medicine | Greenville | North Carolina | United States | 27858-4354 |
| 139 | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | United States | 27157-1081 |
| 140 | Dakota Cancer Institute | Fargo | North Dakota | United States | 58103-4940 |
| 141 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 142 | Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45229-3039 |
| 143 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 144 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 145 | Children's Hospital of Columbus | Columbus | Ohio | United States | 43205-2696 |
| 146 | Children's Medical Center - Dayton | Dayton | Ohio | United States | 45404 |
| 147 | Toledo Children's Hospital | Toledo | Ohio | United States | 43601 |
| 148 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
| 149 | Forum Health-Tod Childrens Hospital | Youngstown | Ohio | United States | 44501 |
| 150 | Children's Hospital of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 151 | CCOP - Oklahoma | Tulsa | Oklahoma | United States | 74136 |
| 152 | Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | United States | 74136 |
| 153 | Doernbecher Children's Hospital | Portland | Oregon | United States | 97201-3098 |
| 154 | Legacy Emanuel Hospital and Health Center | Portland | Oregon | United States | 97227 |
| 155 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-1320 |
| 156 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 157 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 158 | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134-1095 |
| 159 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 160 | Rhode Island Hospital | Providence | Rhode Island | United States | 02818 |
| 161 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 162 | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | United States | 29203 |
| 163 | Children's Hospital of Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 164 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105-1080 |
| 165 | Sioux Valley Hospital | Sioux Falls | South Dakota | United States | 57117 |
| 166 | East Tennessee State University Cancer Center at JCMC | Johnson City | Tennessee | United States | 37604 |
| 167 | East Tennessee Children's Hospital | Knoxville | Tennessee | United States | 37901 |
| 168 | Saint Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105-2794 |
| 169 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 170 | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas | United States | 79106 |
| 171 | Children's Hospital of Austin | Austin | Texas | United States | 78701 |
| 172 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 173 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
| 174 | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | United States | 76104 |
| 175 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0361 |
| 176 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 177 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 178 | San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas | United States | 78236-5300 |
| 179 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 180 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78207 |
| 181 | Methodist Health Care System | San Antonio | Texas | United States | 78229-3902 |
| 182 | Scott and White Memorial Hospital | Temple | Texas | United States | 76508 |
| 183 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 184 | Vermont Cancer Center | Burlington | Vermont | United States | 05401-3498 |
| 185 | Cancer Center at the University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 186 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042-3300 |
| 187 | Children's Hospital of the King's Daughters | Norfolk | Virginia | United States | 23507 |
| 188 | Naval Medical Center, Portsmouth | Portsmouth | Virginia | United States | 23708-5100 |
| 189 | Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 190 | Carilion Medical Center for Children | Roanoke | Virginia | United States | 24013 |
| 191 | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | United States | 98105 |
| 192 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
| 193 | Group Health Cooperative | Seattle | Washington | United States | 98112 |
| 194 | Deaconess Medical Center | Spokane | Washington | United States | 99210-0248 |
| 195 | Mary Bridge Children's Health Center | Tacoma | Washington | United States | 98415-0299 |
| 196 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-5000 |
| 197 | West Virginia University - Charleston | Charleston | West Virginia | United States | 25302 |
| 198 | Cabell-Huntington Hospital, Inc | Huntington | West Virginia | United States | 25701 |
| 199 | West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506-9300 |
| 200 | Bellin Memorial Hospital | Green Bay | Wisconsin | United States | 54301 |
| 201 | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 202 | St. Vincent Hospital | Green Bay | Wisconsin | United States | 54307-9070 |
| 203 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 204 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792-0001 |
| 205 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449-5772 |
| 206 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 207 | Sydney Children's Hospital | Randwick | New South Wales | Australia | 2031 |
| 208 | Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 209 | Royal Children's Hospital | Brisbane | Queensland | Australia | 4029 |
| 210 | Women's and Children's Hospital | North Adelaide | South Australia | Australia | 5006 |
| 211 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 212 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6001 |
| 213 | Alberta Children's Hospital | Calgary | Alberta | Canada | T2T 5C7 |
| 214 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 215 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
| 216 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 217 | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 218 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3J 3G9 |
| 219 | Children's Hospital | Hamilton | Ontario | Canada | L8N 3Z5 |
| 220 | Children's Hospital of Western Ontario | London | Ontario | Canada | N6C 2V5 |
| 221 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 222 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 223 | McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec | Canada | H3H 1P3 |
| 224 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 225 | Centre Hospitalier de L'Universite Laval | Sainte Foy | Quebec | Canada | GIV 4G2 |
| 226 | Laval University Medical Center | Sainte-Foy | Quebec | Canada | G1V 4G2 |
| 227 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 228 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 229 | Academisch Ziekenhuis Groningen | Groningen | Netherlands | 9700 RB | |
| 230 | Starship Children's Hospital | Auckland | New Zealand | ||
| 231 | University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | Puerto Rico | 00936-5067 | |
| 232 | San Jorge Childrens Hospital | Santurce | Puerto Rico | 00912 | |
| 233 | Swiss Pediatric Oncology Group Bern | Bern | Switzerland | CH 3010 | |
| 234 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | CH 1211 | |
| 235 | Swiss Pediatric Oncology Group Lausanne | Lausanne | Switzerland | CH 1011 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Daniel M. Green, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 9440
- COG-Q9401
- NWTS-Q9401
- CCG-4941
- POG-9440
- INT-0150
- NWTS-5
- CDR0000063901