NCT04322318 · Children's Oncology Group
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
What this study is about
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).
View original scientific description
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).
Interventions
PROCEDURE
Biopsy Procedure
Undergo a biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Scan
Undergo a bone scan
DRUG
Carboplatin
Given IV
PROCEDURE
Computed Tomography
Undergo a CT scan
DRUG
Cyclophosphamide
Given IV
DRUG
Doxorubicin
Given IV
DRUG
Etoposide
Given IV
DRUG
Ifosfamide
Given IV
DRUG
Irinotecan
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Positron Emission Tomography
Undergo a PET scan
RADIATION
Radiation Therapy
Undergo RT
PROCEDURE
Surgical Procedure
Undergo surgery
DRUG
Topotecan
Given IV
PROCEDURE
Transabdominal Ultrasound
Undergo abdominal ultrasound
DRUG
Vincristine
Given IV
PROCEDURE
X-Ray Imaging
Undergo a chest x-ray
Primary outcome measures
Event-free survival (EFS) for stratum 1-3
Time frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years from study entry
Kaplan-Meier method will be used to estimate EFS, defined as the time from study entry until relapse or disease progression, secondary malignancy, or death.
EFS for stratum 4
Time frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years from study entry
Kaplan-Meier method will be used to estimate 4-year EFS, defined as the time from study entry until relapse or disease progression, secondary malignancy, or death.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
- Patients must be =\< 30 years old at study enrollment
- Patients with the following diagnoses are eligible for this study:
- Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
- Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defin
Where
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Downey, California
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Madera, California
And 129 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations