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NCT06401330 · ClinicalTrials.gov registry record · Phase 3
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
A Phase 3 study of Stage I Mixed Cell Type Kidney Wilms Tumor and Stage II Mixed Cell Type Kidney Wilms Tumor, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,656
- Enrollment target
- 20
- Study locations
NCT06401330: Recruiting Phase 3 study of Stage I Mixed Cell Type Kidney Wilms Tumor and Stage II Mixed Cell Type Kidney Wilms Tumor, sponsored by Children's Oncology Group.
NCT06401330 is a Phase 3 study of Stage I Mixed Cell Type Kidney Wilms Tumor and Stage II Mixed Cell Type Kidney Wilms Tumor that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 1,656 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06401330, a Phase 3 study of Stage I Mixed Cell Type Kidney Wilms Tumor and Stage II Mixed Cell Type Kidney Wilms Tumor, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,656 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Kaplan-Meier method will be used to estimate 4-year EFS, defined as the time from randomization or first diagnostic nephrectomy or biopsy until relapse or disease progression, secondary malignancy, or death.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- BIOLOGICAL Dactinomycin
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,656 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2031-02-13 |
| Phase | Phase 3 |
What NCT06401330 shows while recruiting
NCT06401330 is an interventional study that assigns participants to a tested intervention. Its 1,656 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (115% higher).
The record links to 4 conditions, with Stage I Mixed Cell Type Kidney Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06401330 names 20 study sites across 8 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT06401330 about?
NCT06401330 is a clinical study titled "A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)". 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 treatmen...
What is the current status of trial NCT06401330?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,656 participants. The study started on 2025-04-15. Estimated completion is 2031-02-13.
What conditions does trial NCT06401330 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT06401330?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT06401330?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06401330 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06401330's enrollment target sits among peer trials
1,656 137th of 2000 higher than 1,864 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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