Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
Children's Oncology Group
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.
Description
PRIMARY OBJECTIVES: I. To maintain event-free survival (EFS) for Stage I favorable histology Wilms tumor (FHWT) patients without adverse biology who are also (1) 2 to \< 4 years of age, OR (2) age \< 2 years with tumor weight of 550 grams or more, OR (3) age 4+ years with epithelial histology subtype while reducing post-nephrectomy therapy from vincristine, actinomycin (EE-4A) to Nephrectomy Only. (Stage I Nephrectomy Only Stratum 2) II. To improve EFS for Stage I FHWT patients with age \< 2 years AND nephrectomy weight \< 550g AND whose tumors have adverse biology by treating with EE-4A inst…
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Patients must enroll on AREN2231 by Day 14. * Exceptions: If patie…
Interventions
- ProcedureBone Scan
Undergo bone scan for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- DrugCyclophosphamide
Given IV
- BiologicalDactinomycin
Given IV
- DrugDoxorubicin
Given IV
- DrugEtoposide
Given IV
Locations (159)
- Children's Hospital of AlabamaBirmingham, Alabama
- USA Health Strada Patient Care CenterMobile, Alabama
- Providence Alaska Medical CenterAnchorage, Alaska
- Banner Children's at DesertMesa, Arizona
- Phoenix Childrens HospitalPhoenix, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas