Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

The purpose of this study is to improve treatment for children and young adults with Wilms tumor, the most common type of kidney cancer in children. The goal is to help keep the cancer from coming back, while reducing side effects from treatment for those who may not need as much.

This study will use test results from each patient's tumor, along with how well the cancer responds to treatment, to match treatment to their risk of the cancer coming back. Some participants will receive standard treatment. Those with a lower risk may receive less treatment, or treatment with fewer expected side effects. Those with a higher risk may receive more treatment to help prevent the cancer from returning.

For full study details, see the study listing on ClinicalTrials.gov (NCT06401330).

This study may be an option for people who meet general guidelines such as:

• Children and adults under 30 years of age
• Newly diagnosed Stage I-IV favorable histology Wilms tumor
• Must have adequate liver and cardiac function

These points are general guidelines only. The study team will review each person's medical information to determine final eligibility.

Taking part in this study may include:

• Surgery to remove the kidney (nephrectomy)
• Assignment to a treatment plan based on the stage of the tumor, the results of tumor tissue and biology tests, and how the tumor responds to treatment
• For some children, observation after surgery without chemotherapy
• For other children, chemotherapy given intravenously (IV) in repeating cycles; the drugs may include vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide, carboplatin, and irinotecan, depending on the assigned plan
• Radiation therapy and/or additional surgery as part of usual care and as determined by your doctor
• Imaging with ultrasound, X-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, positron emission tomography (PET) scans, and bone scans

Participants also have regular lab tests and check-ups during treatment, followed by long-term follow-up visits so the care team can watch for any return of the cancer and for late effects of treatment.