drugset / Trial / NCT00002611
Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
Treatment
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.
Timeline
- Start
- 1995-07
- Primary completion
- 2002-06
- Completion
- 2003-08
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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 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 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 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 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 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Benedetti DJ, Varela CR, Renfro LA, Tornwall B, Dix DB, Ehrlich PF, Glick RD, Kalapurakal J, Perlman E, Gratias E, Seibel NL, Geller JI, Khanna G, Malogolowkin M, Grundy P, Fernandez CV, Dome JS, Mullen EA. Treatment of children with favorable histology Wilms tumor with extrapulmonary metastases: A report from the COG studies AREN0533 and AREN03B2 and NWTSG study NWTS-5. Cancer. 2024 Mar 15;130(6):947-961. doi: 10.1002/cncr.35099. Epub 2023 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Dactinomycin | Protein / enzyme biologic | — | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Comparator | Etoposide | Small molecule | — | Intravenous |
| Comparator | Vincristine | Small molecule | — | Intravenous |
| Comparator | filgrastim | Protein / enzyme biologic | — | Subcutaneous |