Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer - Full Text View

Purpose

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	Intervention	Phase
Kidney Cancer	Biological: dactinomycin Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	207
Study Start Date:	May 2002

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002611

Show 235 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Daniel M. Green, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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. 2010 Dec 28; [Epub ahead of print]

Fernandez CV, Anderson J, Breslow NE, Dome JS, Grundy PE, Perlman EJ, Green DM; The 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. 2008 Nov 6; [Epub ahead of print]

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 Feb 10; [Epub ahead of print]

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. 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. 2007 May 30; [Epub ahead of print]

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.

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.

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.

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

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.

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. Epub 2005 Aug 29.

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.

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 Mar 15. doi: 10.1002/pbc.24123. [Epub ahead of print]

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.

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. Epub 2011 Jun 17.

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.

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 Aug 27; [Epub ahead of print]

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.

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. 2007 Dec 19; [Epub ahead of print]

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.

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.

ClinicalTrials.gov Identifier:	NCT00002611 History of Changes
Other Study ID Numbers:	CDR0000063901, COG-Q9401, NWTS-Q9401, CCG-4941, POG-9440, INT-0150, NWTS-5
Study First Received:	November 1, 1999
Last Updated:	October 25, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Wilms Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn
Dactinomycin
Doxorubicin
Cyclophosphamide
Etoposide
Vincristine
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013