Health Trials

A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)

ConditionsStage I Mixed Cell Type Kidney Wilms TumorStage II Mixed Cell Type Kidney Wilms TumorStage III Mixed Cell Type Kidney Wilms TumorStage IV Mixed Cell Type Kidney Wilms Tumor
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorChildren's Oncology Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.

Patients must be < 30 years old at enrollment.

Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1-REN.

Patients must receive a qualifying Initial Stratum Assignment on APEC14B1-REN by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.

Disqualifiers

Patient with a diagnosis of Stage V Bilateral Wilms Tumor.

Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible.

Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.

Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy

  • Carboplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Cyclophosphamide

    Drug

    Given IV

  • Dactinomycin

    Biological/Vaccine

    Given IV

  • Doxorubicin

    Drug

    Given IV

  • Etoposide

    Drug

    Given IV

  • Irinotecan

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nephrectomy

    Procedure/Surgery

    Undergo nephrectomy

  • Patient Observation

    Other intervention

    Undergo observation after nephrectomy

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy

  • Ultrasound Imaging

    Procedure/Surgery

    Undergo ultrasound

  • Vincristine

    Drug

    Given IV

  • X-Ray Imaging

    Procedure/Surgery

    Undergo X-ray

Treatment groups

1,656 Participants
are divided into 48 treatment groups

48

Treatment groups

See each treatment group below.

Group A: Stage I, Arm I (EE-4A)Experimental treatment 6 interventions
Group B: Stage I, Arm II (observation)Experimental treatment 3 interventions
Group C: Stage I, Arm III (DD-4A)Experimental treatment 7 interventions
Group D: Stage I, Arm IV (UH-3)Experimental treatment 10 interventions
Group E: Stage II, Arm I (EE-4A)Experimental treatment 6 interventions
Group F: Stage II, Arm II (EE-4A, VIVA)Experimental treatment 7 interventions
Group G: Stage II, Arm III (EE-4A, DD-4A)Experimental treatment 7 interventions
Group H: Stage III, Arm I (DD-4A, EE-4A)Experimental treatment 6 interventions
Group I: Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)Experimental treatment 7 interventions
Group J: Stage III, Arm II (DD-4A)Experimental treatment 7 interventions
Group K: Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)Experimental treatment 11 interventions
Group L: Stage III, Arm IIA (MVI)Experimental treatment 12 interventions
Group M: Stage III, Arm IIB (M)Experimental treatment 9 interventions
Group N: Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)Experimental treatment 10 interventions
Group O: Stage III, Arm IV-Upfront/Delayed (DD-4A, M)Experimental treatment 9 interventions
Group P: Stage III, Arm IX-Upfront/Delayed (MVI)Experimental treatment 10 interventions
Group Q: Stage III, Arm V-Upfront/Delayed (DD-4A)Experimental treatment 8 interventions
Group R: Stage III, Arm VA-Upfront/Delayed (DD-4A)Experimental treatment 7 interventions
Group S: Stage III, Arm VB-Upfront/Delayed (M)Experimental treatment 8 interventions
Group T: Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)Experimental treatment 10 interventions
Group U: Stage III, Arm VII-Upfront/Delayed (DD-4A, M)Experimental treatment 9 interventions
Group V: Stage III, Arm VIII-Upfront/Delayed (UH-3)Experimental treatment 10 interventions
Group W: Stage III, Arm X-Upfront/Delayed (M)Experimental treatment 9 interventions
Group X: Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)Experimental treatment 7 interventions
Group Y: Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)Experimental treatment 11 interventions
Group Z: Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)Experimental treatment 10 interventions
Group [: Stage IV Arm IV-Upfront-Delayed (DD-4A, M)Experimental treatment 9 interventions
Group \: Stage IV Arm IX-Upfront-Delayed (MVI)Experimental treatment 10 interventions
Group ]: Stage IV Arm V-Upfront-Delayed (DD-4A)Experimental treatment 8 interventions
Group ^: Stage IV Arm VA-Upfront-Delayed (DD-4A)Experimental treatment 7 interventions
Group _: Stage IV Arm VB-Upfront-Delayed (M)Experimental treatment 9 interventions
Group `: Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)Experimental treatment 12 interventions
Group a: Stage IV Arm VII-Upfront-Delayed (DD-4A, M)Experimental treatment 9 interventions
Group b: Stage IV Arm VIII-Upfront-Delayed (UH-3)Experimental treatment 10 interventions
Group c: Stage IV Arm X-Upfront-Delayed (M)Experimental treatment 11 interventions
Group d: Stage IV Extrapulmonary Arm I (DD-4A, MVI)Experimental treatment 12 interventions
Group e: Stage IV Extrapulmonary Arm II (DD-4A, M)Experimental treatment 11 interventions
Group f: Stage IV Extrapulmonary Arm III (DD-4A, MVI)Experimental treatment 11 interventions
Group g: Stage IV Extrapulmonary Arm IV (DD-4A, M)Experimental treatment 11 interventions
Group h: Stage IV Extrapulmonary Arm IX (MVI)Experimental treatment 11 interventions
Group i: Stage IV Extrapulmonary Arm V (DD-4A, UH-3)Experimental treatment 13 interventions
Group j: Stage IV Extrapulmonary Arm VI (DD-4A, MVI)Experimental treatment 12 interventions
Group k: Stage IV Extrapulmonary Arm VII (DD-4A, M)Experimental treatment 11 interventions
Group l: Stage IV Extrapulmonary Arm VIII (UH-3)Experimental treatment 12 interventions
Group m: Stage IV Extrapulmonary Arm X (M)Experimental treatment 10 interventions
Group n: Stage IV Lung Metastases Arm I (DD-4A)Experimental treatment 7 interventions
Group o: Stage IV Lung Metastases Arm II (DD-4A, MVI)Experimental treatment 10 interventions
Group p: Stage IV Lung Metastases Arm III (DD-4A, M)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Event-free survival (EFS)

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.

Time frame
Up to 4 years from study entry

Secondary outcomes

1

Overall survival (OS)

Kaplan-Meier method will be used to estimate 4-year OS, defined as the time from randomization until death.

Time frame
Up to 4 years from study entry

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Oncology Group

Lead sponsor

Source ClinicalTrials.gov
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