A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)

Summary

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.

Conditions

• Stage I Mixed Cell Type Kidney Wilms Tumor
• Stage II Mixed Cell Type Kidney Wilms Tumor
• Stage III Mixed Cell Type Kidney Wilms Tumor
• Stage IV Mixed Cell Type Kidney Wilms Tumor

Interventions

PROCEDURE

Bone Scan

Undergo bone scan for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

DRUG

Irinotecan

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Nephrectomy

Undergo nephrectomy

OTHER

Patient Observation

Undergo observation after nephrectomy

PROCEDURE

Positron Emission Tomography

Undergo PET for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy

PROCEDURE

Ultrasound Imaging

Undergo ultrasound

DRUG

Vincristine

Given IV

PROCEDURE

X-Ray Imaging

Undergo X-ray

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Elizabeth A Mullen · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2031-02-13

Completion

2031-02-13

FDA Drug

Yes

Countries

• United States
• Australia
• Canada

Study Locations