COG-AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study

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COG-AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study

1. To improve 4 year event-free survival (EFS) to 73% for patients with bilateral Wilms tumor (BWT).
2. To prevent complete removal of at least one kidney in 50% of patients with BWT by using 3-drug chemotherapy induction with vincristine, dactinomycin and doxorubicin, prior to kidney surgery.
3. To evaluate the efficacy of chemotherapy in preserving normal kidney tissue in children with diffuse hyperplastic perilobar nephrogenic rests (DHPLNR) and preventing Wilms tumor development.
4.To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.
5. To have 75% of children with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy.

Protocol Number110907
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesKidney
Therapies InvolvedSurgery
Radiotherapy
Participating InstitutionsRutgers Cancer Institute of New Jersey
Robert Wood Johnson Medical School

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.