Phase 3Recruiting

Comparing 48 approaches for stage i mixed cell type kidney wilms tumor

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

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

Condition: Stage I Mixed Cell Type Kidney Wilms TumorSponsor: Children's Oncology GroupTarget enrollment: 1656

Phase 3
48 groups
Sites in Québec, Calgary and 9 more cities
Recruiting

Interventions (15)

Medical procedure
Bone Scan
Undergo bone scan for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy
Medication
Carboplatin
Given IV
Medical procedure
Computed Tomography
Undergo CT
Medication
Cyclophosphamide
Given IV
Biological therapy
Dactinomycin
Given IV
Medication
Doxorubicin
Given IV
Medication
Etoposide
Given IV
Medication
Irinotecan
Given IV
Medical procedure
Magnetic Resonance Imaging
Undergo MRI
Medical procedure
Nephrectomy
Undergo nephrectomy
Other intervention
Patient Observation
Undergo observation after nephrectomy
Medical procedure
Positron Emission Tomography
Undergo PET for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy
Medical procedure
Ultrasound Imaging
Undergo ultrasound
Medication
Vincristine
Given IV
Medical procedure
X-Ray Imaging
Undergo X-ray

Canadian Sites (12)

11 of 12 recruiting

University of Alberta Hospital
Edmonton, Alberta
Recruiting
CancerCare Manitoba
Winnipeg, Manitoba
Recruiting
IWK Health Centre
Halifax, Nova Scotia
Recruiting
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario
Recruiting
Children's Hospital
London, Ontario
Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Recruiting
Hospital for Sick Children
Toronto, Ontario
Recruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec
Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec
Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec
Recruiting
Alberta Children's Hospital
Calgary, Alberta
Paused

See who this study is looking for41 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
+Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
+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.
+Patients must enroll on AREN2231 by Day 14.
+Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or biopsy) without receiving an Initial Stratum Assignment on APEC14B1-REN, patient will not be eligible for enrollment on AREN2231 unless all required materials (reports and Case Report Forms and specimens) for an Initial Stratum Assignment arrived by Day 7, but an Initial Stratum Assignment was not completed by Day 14. In these circumstances, after obtaining appropriate protocol consent, the patient may proceed with treatment according to local institutional staging and enroll within 5 calendar days of notification of the central Initial Stratum Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in agreement with any treatment already initiated. If the Initial Stratum Assignment is not in agreement with the local institution's assessment then the patient will be ineligible for AREN2231.
+All sites must have sent or plan to send diagnostic tumor sample for molecular testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or equivalent if outside of the United States \[US\]) laboratory that can detect Loss of Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients potentially eligible for mVLR must also have LOH of chromosome 11p15 included.
+Note: Patients are eligible for enrollment prior to obtaining these molecular testing results, and it is strongly recommended that patients are enrolled before these results are available. However, molecular results must be returned and uploaded to APEC14B1-REN for integration into risk stratification by the required timepoints (specific timelines vary by treatment arm). Patients who do not have molecular results available by the arm-specific timepoints may be taken off protocol therapy.
+Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible.
+Note: Lymph node sampling will also be required at delayed nephrectomy. Patients who do not have a lymph node sampled and confirmed as a lymph node by central pathology review at delayed nephrectomy will be taken off protocol therapy.
+Karnofsky performance status must be ≥ 50 for patients \> 16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.
+Note: This criteria only applies to patients centrally classified as Stage IV. Stage II and III patients subsequently assigned to a doxorubicin arm will be off protocol therapy if they do not meet this criteria at time of cardiac function assessment.
+All patients and/or their parents or legal guardians must sign a written informed consent.
+ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X ULN for subjects with total bilirubin levels \> 1.5 ULN (within 7 days prior to enrollment).
+ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Aspartate aminotransferase (AST/serum glutamate oxaloacetic transaminase \[SGOT\]) OR alanine transaminase (ALT/serum glutamic pyruvate transaminase \[SGPT\]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).
+ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)

Exclusion

−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.
−In the context of the renal tumor protocols, multicentric tumors and multifocal tumors are equivalent terms, and refer to the occurrence of two or more tumors arising within one kidney.
−Exclusion from the Nephrectomy Only arm applies to two groups of patients:
−Patients \< 4 years with Stage I FHWT other than epithelial subtype AND
−Stage I patients of any age with Epithelial WT
−For the purpose of exclusion from the Nephrectomy Only Arm, known or suspected WT predisposition syndromes or conditions are defined as follows:
−WT Predisposition Syndromes: Beckwith Wiedemann Spectrum, Denys Drash, Trisomy 18, Idiopathic Hemihypertrophy/Isolated Lateralized Overgrowth, WAGR, Simpson-Golabi-Behmel, Bohring-Opitz, or other conditions considered by treating physician to predispose to WT.
−WT Predisposing Conditions:
−A unilateral WT and (radiologic or pathologic) determination of contralateral nephrogenic rest(s) AND/OR
−Unilateral multicentric WT
−Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.
−Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor.
−Please note: Those with lung metastases as the only metastatic site who have complete resection of all radiologically evident lung nodules after enrollment but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable for lung assessment and subsequent stratum assignment and will, therefore, come off protocol therapy.
−Patients with known Charcot-Marie-Tooth syndrome.
−Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.
−Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
−Lactating females who plan to breastfeed their infants.
−Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
−Patients who have had prior tumor-directed chemotherapy or radiotherapy for the current diagnosis except for therapy delivered for an emergent issue, as medically indicated.
−Patients receiving concurrent chemotherapy for a different diagnosis.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 3 — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 48 groups in this study.

Groups A, E and H receive one or more of: Computed Tomography, Dactinomycin, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: A: Stage I, Arm I (EE-4A) · E: Stage II, Arm I (EE-4A) · H: Stage III, Arm I (DD-4A, EE-4A)

Group B receives one or more of: Patient Observation, Ultrasound Imaging and X-Ray Imaging.

Registry label: B: Stage I, Arm II (observation)

Groups C, G, I, J, R, X, AD and AT receive one or more of: Computed Tomography, Dactinomycin, Doxorubicin, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: C: Stage I, Arm III (DD-4A) · G: Stage II, Arm III (EE-4A, DD-4A) · I: Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A) · J: Stage III, Arm II (DD-4A) · R: Stage III, Arm VA-Upfront/Delayed (DD-4A) · X: Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A) · AD: Stage IV Arm VA-Upfront-Delayed (DD-4A) · AT: Stage IV Lung Metastases Arm I (DD-4A)

Groups D, V and AH receive one or more of: Carboplatin, Computed Tomography, Cyclophosphamide, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: D: Stage I, Arm IV (UH-3) · V: Stage III, Arm VIII-Upfront/Delayed (UH-3) · AH: Stage IV Arm VIII-Upfront-Delayed (UH-3)

Group F receives one or more of: Computed Tomography, Dactinomycin, Irinotecan, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: F: Stage II, Arm II (EE-4A, VIVA)

Groups K and Y receive one or more of: Carboplatin, Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: K: Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3) · Y: Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)

Groups L, AF, AJ and AP receive one or more of: Bone Scan, Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: L: Stage III, Arm IIA (MVI) · AF: Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI) · AJ: Stage IV Extrapulmonary Arm I (DD-4A, MVI) · AP: Stage IV Extrapulmonary Arm VI (DD-4A, MVI)

Groups M, O, U, W, AA, AE, AG and AV receive one or more of: Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: M: Stage III, Arm IIB (M) · O: Stage III, Arm IV-Upfront/Delayed (DD-4A, M) · U: Stage III, Arm VII-Upfront/Delayed (DD-4A, M) · W: Stage III, Arm X-Upfront/Delayed (M) · AA: Stage IV Arm IV-Upfront-Delayed (DD-4A, M) · AE: Stage IV Arm VB-Upfront-Delayed (M) · AG: Stage IV Arm VII-Upfront-Delayed (DD-4A, M) · AV: Stage IV Lung Metastases Arm III (DD-4A, M)

Groups N, P, T, Z, AB and AU receive one or more of: Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: N: Stage III, Arm III-Upfront/Delayed (DD-4A, MVI) · P: Stage III, Arm IX-Upfront/Delayed (MVI) · T: Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI) · Z: Stage IV Arm III-Upfront-Delayed (DD-4A, MVI) · AB: Stage IV Arm IX-Upfront-Delayed (MVI) · AU: Stage IV Lung Metastases Arm II (DD-4A, MVI)

Groups Q and AC receive one or more of: Computed Tomography, Dactinomycin, Doxorubicin, Magnetic Resonance Imaging, Nephrectomy, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: Q: Stage III, Arm V-Upfront/Delayed (DD-4A) · AC: Stage IV Arm V-Upfront-Delayed (DD-4A)

Group S receives one or more of: Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Magnetic Resonance Imaging, Ultrasound Imaging and X-Ray Imaging.

Registry label: S: Stage III, Arm VB-Upfront/Delayed (M)

Groups AI, AK, AM and AQ receive one or more of: Bone Scan, Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AI: Stage IV Arm X-Upfront-Delayed (M) · AK: Stage IV Extrapulmonary Arm II (DD-4A, M) · AM: Stage IV Extrapulmonary Arm IV (DD-4A, M) · AQ: Stage IV Extrapulmonary Arm VII (DD-4A, M)

Group AL receives one or more of: Bone Scan, Computed Tomography, Cyclophosphamide, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AL: Stage IV Extrapulmonary Arm III (DD-4A, MVI)

Group AN receives one or more of: Bone Scan, Computed Tomography, Dactinomycin, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AN: Stage IV Extrapulmonary Arm IX (MVI)

Group AO receives one or more of: Bone Scan, Carboplatin, Computed Tomography, Cyclophosphamide, Dactinomycin, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AO: Stage IV Extrapulmonary Arm V (DD-4A, UH-3)

Group AR receives one or more of: Bone Scan, Carboplatin, Computed Tomography, Cyclophosphamide, Doxorubicin, Etoposide, Irinotecan, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AR: Stage IV Extrapulmonary Arm VIII (UH-3)

Group AS receives one or more of: Bone Scan, Computed Tomography, Cyclophosphamide, Doxorubicin, Etoposide, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging, Vincristine and X-Ray Imaging.

Registry label: AS: Stage IV Extrapulmonary Arm X (M)

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a maximum age of 30 years.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.maximumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 1,656 people.

The study is currently expected to finish around February 2031.

The main measurement is taken over: Up to 4 years from study entry.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Event-free survival (EFS) — measured over Up to 4 years from study entry.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06401330 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Bone ScanProcedure

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