Treatment Options Under Clinical Evaluation
Current Clinical Trials

For favorable-histology tumors (the 4-year relapse-free survival rate is 90%, and the 4-year overall survival [OS] rate is 95%) with or without focal anaplasia:[1]

• Nephrectomy with lymph node sampling, abdominal radiation, and 24 weeks of chemotherapy with vincristine, doxorubicin, and pulse-intensive dactinomycin (NWTS Regimen DD-4A).

For diffuse or focal anaplastic tumors (the 4-year event-free survival [EFS] rate is 68.3% and 72.0%; for patients who received preoperative chemotherapy, the 4-year EFS rate is 54.2%, and the OS rate is 58%):[2]

• Nephrectomy with lymph node sampling, abdominal radiation, and 24 weeks of chemotherapy with vincristine, doxorubicin, etoposide, cyclophosphamide, and mesna (NWTS Regimen I).[2]

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

Favorable histology

• AREN0532:[3] Patients in this study will be treated with standard therapy of DD-4A (vincristine, dactinomycin, and doxorubicin) for 24 weeks and radiation therapy. Patients who have loss of heterozygosity at chromosomes 1p and 16q will be moved to AREN0533 with regimen M (consisting of vincristine, dactinomycin, and doxorubicin alternating with cyclophosphamide and etoposide) for a total of 24 weeks and radiation therapy.

Focal anaplasia

• AREN0321:[4] In this trial, patients with stage III will be treated with standard DD-4A (vincristine, dactinomycin, and doxorubicin) for 24 weeks and radiation therapy.

Diffuse anaplasia

• AREN0321:[4] In this trial, 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 III 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. 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]
   
   
3. 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]
   
   
4. 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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