Treatment Options Under Clinical Evaluation
Current Clinical Trials

For favorable-histology tumors (the 4-year relapse-free survival rate is 85%, and the 4-year overall survival [OS] rate is 96%):[1,2]

• Nephrectomy with lymph node sampling and 18 weeks of chemotherapy with vincristine and pulse-intensive dactinomycin.

For focal anaplastic tumors (the 4-year event-free survival [EFS] rate is 82.1%, and the OS rate is 81.2%):[3]

• Nephrectomy with lymph node sampling, abdominal radiation, and 24 weeks of chemotherapy with vincristine, doxorubicin, and pulse-intensive dactinomycin.[3]

For diffuse anaplastic tumors (the 4-year EFS rate is 82.1%, and the OS rate is 81.2%):[3]

• Nephrectomy with lymph node sampling, abdominal radiation, and 24 weeks of chemotherapy with vincristine, doxorubicin, etoposide, cyclophosphamide, and mesna.[3]

The following treatment options are currently under investigaton in national and/or institutional clinical trials. Information about ongoing clinical trials is available from the NCI Web site.

Favorable histology

• AREN0532:[4] In this study, all tumors will be stratified based on central pathology review and molecular analysis (loss of heterozygosity [LOH] at chromosomes 1p and 16q). Patients with LOH at 1p and 16q will be upstaged to receive treatment with DD-4A (dactinomycin, doxorubicin, and vincristine) for 24 weeks. Stage II patients will be treated with standard therapy EE-4A (dactinomycin and vincristine) for 18 weeks postnephrectomy.

Focal anaplasia

• Patients with stage II will be treated with standard DD-4A (vincristine, dactinomycin, and doxorubicin) for 24 weeks and radiation therapy.

Diffuse anaplasia

• AREN0321:[5] In this study, patients will be treated with the UH-1 regimen (cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin, and cyclophosphamide) for 30 weeks and radiation therapy.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II Wilms tumor. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Green DM, Breslow NE, Beckwith JB, et al.: Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: a report from the National Wilms' Tumor Study Group. J Clin Oncol 16 (1): 237-45, 1998.  [PUBMED Abstract]
   
   
2. Green DM, Breslow NE, Beckwith JB, et al.: Effect of duration of treatment on treatment outcome and cost of treatment for Wilms' tumor: a report from the National Wilms' Tumor Study Group. J Clin Oncol 16 (12): 3744-51, 1998.  [PUBMED Abstract]
   
   
3. 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]
   
   
4. Fernandez CV, Children's Oncology Group: Phase III Study of Adjuvant Vincristine and Dactinomycin With or Without Doxorubicin Hydrochloride and Radiotherapy or Observation Only in Younger Patients Who are Undergoing Nephrectomy for Newly Diagnosed Stage I-III Favorable Histology Wilms' Tumor, COG-AREN0532, Clinical trial, Active.  [PDQ Clinical Trial]
   
   
5. Dome JS, Children's Oncology Group: Phase II Study of Combination Chemotherapy, Radiotherapy, and/or Surgery in Patients With High-Risk Renal Tumors, COG-AREN0321, Clinical trial, Active.  [PDQ Clinical Trial]
   
   

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