NCT00379340|Active Not RecruitingPhase 3Results

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

AREN0533NCI-2009-00419CDR0000496508U10CA098543U10CA180886

Study Type

interventional

Target

395

Locations

7 countries

Sites

227

Timeline

RegisteredSep 2006

StartedApr 2007

CompletionNov 2026

Brief Summary

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

395

participants targeted

Target at P50-P75 for phase_3

Timeline

6mo left

Started Apr 2007

Longer than P75 for phase_3

Geographic Reach

7 countries

227 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

19.6 years study duration

Study Progress97%

Apr 2007Nov 2026

First Submitted

Initial submission to the registry

September 19, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed

7 months until next milestone

Study Start

First participant enrolled

April 30, 2007

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed

12 months until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed

9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2026

Expected

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

9.2 years

First QC Date

September 19, 2006

Results QC Date

December 6, 2016

Last Update Submit

March 4, 2026

Conditions

Stage III Kidney Wilms Tumor Stage IV Kidney Wilms Tumor

Outcome Measures

Primary Outcomes (3)

Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
4 years
Event Free Survival (EFS) Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
At 4 years
Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study
At 4 years

Secondary Outcomes (1)

Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
At 4 years

Study Arms (1)

Treatment (chemotherapy, surgery, radiotherapy)

EXPERIMENTAL

REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy. Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M. REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.

Radiation: 3-Dimensional Conformal Radiation TherapyProcedure: Conventional SurgeryDrug: CyclophosphamideBiological: DactinomycinDrug: Doxorubicin HydrochlorideDrug: EtoposideDrug: Vincristine Sulfate Liposome

Interventions

3-Dimensional Conformal Radiation TherapyRADIATION

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)