About this trial
This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.
Eligibility criteria
Qualifiers
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.
Patients must receive a qualifying Initial Stratum Assignment on APEC14B1-REN by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.
Disqualifiers
Patient with a diagnosis of Stage V Bilateral Wilms Tumor.
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible.
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.
Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.
Trial design
Treatments tested in this trial
- Bone Scan
- Carboplatin
- Computed Tomography
- Cyclophosphamide
- Dactinomycin
- Doxorubicin
- Etoposide
- Irinotecan
- Magnetic Resonance Imaging
- Nephrectomy
- Patient Observation
- Positron Emission Tomography
- Ultrasound Imaging
- Vincristine
- X-Ray Imaging
Treatment groups
48
Treatment groupsSee each treatment group below.