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Phase III Multimodality Therapy Based on Histology, Stage, Age, and Tumor Size in Children With Wilms' Tumor, Clear Cell Sarcoma of the Kidney, or Rhabdoid Tumors of the Kidney
Alternate Title Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 207A 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.) Outline This is a multicenter study. Patients are assigned to one of nine strata based on tumor histology, stage, tumor weight, and age.
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. Published ResultsFernandez CV, Anderson J, Breslow NE, et al.: Anthropomorphic measurements and event-free survival in patients with favorable histology Wilms tumor: a report from the Children's Oncology Group. Pediatr Blood Cancer 52 (2): 254-8, 2009.[PUBMED Abstract] Huang CC, Gadd S, Breslow N, et al.: 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.[PUBMED Abstract] Malogolowkin M, Cotton CA, Green DM, et al.: 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 50 (2): 236-41, 2008.[PUBMED Abstract] Dome JS, Cotton CA, Perlman EJ, et al.: Treatment of anaplastic histology Wilms' tumor: results from the fifth National Wilms' Tumor Study. J Clin Oncol 24 (15): 2352-8, 2006.[PUBMED Abstract] Ehrlich PF, Hamilton TE, Grundy P, et al.: 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 41 (1): 162-7; discussion 162-7, 2006.[PUBMED Abstract] 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, et al.: High telomerase RNA expression level is an adverse prognostic factor for favorable-histology Wilms' tumor. J Clin Oncol 23 (36): 9138-45, 2005.[PUBMED Abstract] Ehrlich PF, Ritchey ML, Hamilton TE, et al.: Quality assessment for Wilms' tumor: a report from the National Wilms' Tumor Study-5. J Pediatr Surg 40 (1): 208-12; discussion 212-3, 2005.[PUBMED Abstract] Grundy PE, Breslow NE, Li S, et al.: 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 23 (29): 7312-21, 2005.[PUBMED Abstract] Miller MA, Karacay B, Breslow NE, et al.: Prognostic value of quantifying apoptosis factor expression in favorable histology wilms tumors. J Pediatr Hematol Oncol 27 (1): 11-4, 2005.[PUBMED Abstract] Related PublicationsRitchey M, Daley S, Shamberger RC, et al.: Ureteral extension in Wilms' tumor: a report from the National Wilms' Tumor Study Group (NWTSG). J Pediatr Surg 43 (9): 1625-9, 2008.[PUBMED Abstract] van den Heuvel-Eibrink MM, Grundy P, Graf N, et al.: 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 50 (6): 1130-4, 2008.[PUBMED Abstract] Breslow NE, Beckwith JB, Perlman EJ, et al.: Age distributions, birth weights, nephrogenic rests, and heterogeneity in the pathogenesis of Wilms tumor. Pediatr Blood Cancer 47 (3): 260-7, 2006.[PUBMED Abstract] Kalapurakal JA, Nan B, Norkool P, et al.: 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 60 (5): 1379-84, 2004.[PUBMED Abstract] Trial Lead Organizations Children's Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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