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NCT04322318 · ClinicalTrials.gov registry record · Phase 2
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
A Phase 2 study of Recurrent Kidney Wilms Tumor and Stage III Kidney Wilms Tumor, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT04322318: Recruiting Phase 2 study of Recurrent Kidney Wilms Tumor and Stage III Kidney Wilms Tumor, sponsored by Children's Oncology Group.
NCT04322318 is a Phase 2 study of Recurrent Kidney Wilms Tumor and Stage III Kidney Wilms Tumor that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 256 participants, above the 12-participant average among 3 other Recurrent Kidney Wilms Tumor trials with a reported enrollment target (2033% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04322318, a Phase 2 study of Recurrent Kidney Wilms Tumor and Stage III Kidney Wilms Tumor, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study Summary
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). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - 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
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
What NCT04322318 shows while recruiting
NCT04322318 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 12-participant average among 3 other Recurrent Kidney Wilms Tumor trials with a reported enrollment target (2033% higher).
The record links to 5 conditions, with Recurrent Kidney Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04322318 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04322318 about?
NCT04322318 is a clinical study titled "A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT". 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). Drugs used in chemotherapy regimens such as UH-3 (vincristine, d...
What is the current status of trial NCT04322318?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2020-10-19. Estimated completion is 2027-07-01.
What conditions does trial NCT04322318 study?
This clinical trial studies the following conditions: Recurrent Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor, Anaplastic Kidney Wilms Tumor.
What interventions are being tested in trial NCT04322318?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT04322318?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04322318 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.
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