Clinical trialNCT04322318RecruitingPhase 2Interventional

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

SponsorChildren's Oncology GroupEnrollment256Anaplastic Kidney Wilms TumorRecurrent Kidney Wilms TumorStage II Kidney Wilms TumorStage III Kidney Wilms TumorStage IV Kidney Wilms Tumor

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

James I Geller
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

204 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

John Hunter Children'S Hospital
Hunter Regional Mail Centre, New South Wales, Australia
Suspended
Sydney Children'S Hospital
Randwick, New South Wales, Australia
Suspended
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Suspended
Queensland Children'S Hospital
South Brisbane, Queensland, Australia
Steven A. Foresto
Recruiting
Women'S and Children'S Hospital-Adelaide
North Adelaide, South Australia, Australia
Maria L. Kirby
Recruiting
Monash Medical Center-Clayton Campus
Clayton, Victoria, Australia
Suspended
Royal Children'S Hospital
Parkville, Victoria, Australia
Martin A. Campbell
Recruiting
Perth Children'S Hospital
Perth, Western Australia, Australia
Marianne B. Phillips
Recruiting

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
Victor A. Lewis
Recruiting
University of Alberta Hospital
Edmonton, Alberta, Canada
Sarah J. McKillop
Recruiting
British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Rebecca J. Deyell
Recruiting
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Stephanie M. Villeneuve
Recruiting
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
Lisa A. Goodyear
Recruiting
Iwk Health Centre
Halifax, Nova Scotia, Canada
Craig Erker
Recruiting
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Uma H. Athale
Recruiting
Children'S Hospital
London, Ontario, Canada
Shayna M. Zelcer
Recruiting
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Donna L. Johnston
Recruiting
Hospital for Sick Children
Toronto, Ontario, Canada
Avram E. Denburg
Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Monia Marzouki
Recruiting
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Sharon B. Abish
Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Josee Brossard
Recruiting
Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)
Québec, Canada
Bruno Michon
Recruiting

New Zealand

Starship Children'S Hospital
Grafton, Auckland, New Zealand
Mandy PohLui de Silva
Recruiting
Christchurch Hospital
Christchurch, New Zealand
Amanda J. Lyver
Recruiting

Puerto Rico

Hima San Pablo Oncologic Hospital
Caguas, Puerto Rico
Active, not recruiting
University Pediatric Hospital
San Juan, Puerto Rico
Maria E. Echevarria
Recruiting

Saudi Arabia

King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
Suspended

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Elizabeth D. Alva
Recruiting
Usa Health Strada Patient Care Center
Mobile, Alabama, United States
Hamayun Imran
Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, United States
Brenda J. Wittman
Recruiting
Banner Children'S at Desert
Mesa, Arizona, United States
Joseph C. Torkildson
Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Alok K. Kothari
Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Michelina de la Maza
Recruiting
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Michael W. Bishop
Recruiting
Kaiser Permanente Downey Medical Center
Downey, California, United States
Neha G. Vaghasia
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Albert Kheradpour
Recruiting
Miller Children'S and Women'S Hospital Long Beach
Long Beach, California, United States
Jacqueline N. Casillas
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Leo Mascarenhas
Recruiting
Children'S Hospital Los Angeles
Los Angeles, California, United States
Rachana Shah
Recruiting
Mattel Children'S Hospital Ucla
Los Angeles, California, United States
Satiro N. De Oliveira
Recruiting

164 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin →Cyclophosphamide →Doxorubicin →Etoposide →Ifosfamide →Irinotecan →Topotecan →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Oct 2020
Primary completion: 1 Jul 2027
Completion: 1 Jul 2027
Last update posted: 5 May 2026
Registered enrollment: 256
Registry id: NCT04322318

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.