A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
-
Clinical Trial Information
Trial Contact: Parker, Melanie; Armatti, Julie M; Frankos, Marie; Torrescano, Tanner; Jones, Jamie; Singh, Sarah H
Trial Phone: 321-843-1036 ; 321-843-5284 ; 321-842-8738 ; 321-841-8271 ; 3218412008 ; 321.841.7561
-
IRB No: C25.109.05
Protocol Abbrev: AREN2231
Principal Investigator: Jaime C Gonzalez, MD
Phase: Drug: Phase III
Age Group: Pediatric; Adult
Secondary Protocol No: AREN2231
Treatment: Procedure: Bone Scan, Drug: Carboplatin, Procedure: Computed Tomography, Drug: Cyclophosphamide, Biological: Dactinomycin, Drug: Doxorubicin, Drug: Etoposide, Drug: Irinotecan, Procedure: Magnetic Resonance Imaging, Procedure: Nephrectomy, Other: Patient Observation, Procedure: Positron Emission Tomography, Procedure: Ultrasound Imaging, Drug: Vincristine, Procedure: X-Ray Imaging
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT06401330
-
Objective
- To maintain/improve event free survival for the following stages - Stage I Nephrectomy Only Stratum 2, Stage I EE-4A Stratum 3
- Evaluate changes in treatment for the following stages - Stage II: VIVA vs DD-4A Randomization, Stage III: EE-4A
- Demonstrating differences in regimens for the following stages - Stage III: Regimen MVI vs Regimen M Randomization, Stage IV: Regimen MVI vs Regimen M Randomization, Stage III-IV: UH-3 (Blastemal Predominance) -
Key Eligibility
Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.
Patients must be < 30 years old at enrollment.
Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1.
