Clinical Trial for Patients With a Stage IV Childhood Renal Tumor, Comparing Upfront Vincristine, Actinomycin-D and Doxorubicin (Standard Arm) With Upfront Vincristine, Carboplatin and Etoposide (Experimental Arm)

Nephroblastoma (Wilms tumor, WT) is the most common renal tumor of childhood representing ± 6% of all childhood malignancies. The diagnosis is established on clinical and radiological grounds. Metastases are visible on conventional imaging in at least 12% of nephroblastoma patients; however, an additional \~15% of patients have nodules on CT-scan only. The treatment consists of neoadjuvant (preoperative) chemotherapy, nephrectomy and risk-based adjuvant chemotherapy ± radiation therapy (RT) to the flank and/or metastases. For truly localized tumors, overall survival is \> 85% (high risk histology excluded). Several high risk biological characteristics have been identified: diffuse anaplasia, gain of 1q chromosome, loss of heterozygosity 1p + 16q, blastemal residual volume. For metastatic nephroblastoma, the standard neo-adjuvant chemotherapy includes 3 drugs: vincristine, actinomycin-D and doxorubicin (VAD). Long-term survival is 82% (1). However, two issues arise. First, the use of doxorubicin ± concomitant RT might be associated with cardiac and pulmonary sequelae (4-17% of congestive heart failure) (2), and actinomycin-D is associated with hepatic toxicity (3). Second, patients with "CT-only" nodules are treated according to "localized disease". However, their outcome is poorer than that of truly "localized disease" (4-6). The efficacy of carboplatin and etoposide is known for a long time; these drugs are used as second line treatment or for high-risk histology nephrobla…

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