[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546927":3},{"organization":4,"armGroups":7,"interventions":216,"overallOfficials":441,"centralContacts":357,"locations":445,"responsibleParty":2737,"collaborators":357,"id":2739,"slug":357,"hasResults":2740,"nctId":2741,"briefTitle":2742,"officialTitle":2743,"acronym":357,"eligibilityCriteria":2744,"healthyVolunteers":2740,"sex":2745,"minAge":357,"maxAge":2746,"enrollmentInfo":2747,"targetDuration":357,"studyType":2750,"phases":2751,"briefSummary":2753,"conditions":2754,"keywords":357,"overallStatus":448,"whyStopped":357,"lastUpdateSubmitDate":2759,"lastUpdatePostDateStruct":2760,"startDateStruct":2763,"completionDateStruct":2765,"leadSponsor":2767,"locationsCount":2768},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,19,24,29,37,41,45,49,53,57,61,65,71,75,79,83,87,92,96,100,104,108,112,116,120,124,128,132,136,140,144,148,152,156,160,164,168,172,176,180,184,188,192,196,200,204,208,212],{"label":9,"type":10,"description":11,"interventionNames":12},"Stage I, Arm I (EE-4A)","EXPERIMENTAL","Patients receive regimen EE-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 1-7 and vincristine IV on days 1, 8, \\& 15 of cycles 1-3 and day 1 of cycles 4-7. Treatment repeats every 21 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,15,16,17,18],"Procedure: Computed Tomography","Biological: Dactinomycin","Procedure: Magnetic Resonance Imaging","Procedure: Ultrasound Imaging","Drug: Vincristine","Procedure: X-Ray Imaging",{"label":20,"type":10,"description":21,"interventionNames":22},"Stage I, Arm II (observation)","Patients undergo observation without chemotherapy on study with ultrasounds and x-rays.",[23,16,18],"Other: Patient Observation",{"label":25,"type":10,"description":26,"interventionNames":27},"Stage I, Arm III (DD-4A)","Patients receive regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 1, 3, 5, 7, \\& 9, vincristine IV on days 1, 8, \\& 15 of cycles 1-3 and day 1 of cycles 4-9, doxorubicin IV over 3-15 minutes on day 1 of cycles 2, 4, 6, \\& 8. Treatment repeats every 21 days for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],"Drug: Doxorubicin",{"label":30,"type":10,"description":31,"interventionNames":32},"Stage I, Arm IV (UH-3)","Patients receive regimen UH-3: Vincristine IV on days 1, 8, \\& 15 of cycles 1, 5, 7, 10, \\& 13, and days 1 \\& 8 of cycles 3, 4, 8, \\& 11, doxorubicin IV 3-15 minutes on day 1 of cycles 1, 5, 7, 10, \\& 13, cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1, 5, 7, 10, \\& 13, and days 1-4 of cycles 2, 6, 9, 12, \\& 14, carboplatin IV over 15-60 minutes on day 1 of cycles 2, 6, 9, 12, and 14, etoposide IV over 60-120 minutes on days 1-4 of cycles 2, 6, 9, 12, \\& 14, and irinotecan IV over 90 minutes on days 1-5 of cycles 3, 4, 8, \\& 11. Treatment repeats every 21 days for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[33,13,34,28,35,36,15,16,17,18],"Drug: Carboplatin","Drug: Cyclophosphamide","Drug: Etoposide","Drug: Irinotecan",{"label":38,"type":10,"description":39,"interventionNames":40},"Stage II, Arm I (EE-4A)","Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-7 of regimen EE-4A as in STAGE I FHWT Arm I. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,15,16,17,18],{"label":42,"type":10,"description":43,"interventionNames":44},"Stage II, Arm II (EE-4A, VIVA)","Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-9 of regimen VIVA: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 5, 7, \\& 9, vincristine IV on days 1, 8, \\& 15 of cycles 2-3 and day 1 of cycles 4-9, irinotecan IV over 90 minutes daily on days 1-5 of cycles 2, 4, 6, \\& 8. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,36,15,16,17,18],{"label":46,"type":10,"description":47,"interventionNames":48},"Stage II, Arm III (EE-4A, DD-4A)","Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-9 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 5, 7, and 9, vincristine IV on days 1, 8, and 15 of cycles 2-3 and day 1 of cycles 4-9, and doxorubicin IV over 3-15 minutes on day 1 of cycles 2, 4, 6, \\& 8. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":50,"type":10,"description":51,"interventionNames":52},"Stage III, Arm I (DD-4A, EE-4A)","Patients able to undergo an upfront nephrectomy receive cycle 1 treatment of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, \\& 15 of cycle 1. Patients with standard biology receive cycles 2-7 of regimen EE-4A as in STAGE I FHWT Arm I. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,15,16,17,18],{"label":54,"type":10,"description":55,"interventionNames":56},"Stage III, Arm I-Upfront\u002FDelayed (DD-4A, EE-4A)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Patients with standard biology and low intermediate risk histology receive cycles 3-7 of regimen EE-4A as in STAGE I FHWT Arm I above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":58,"type":10,"description":59,"interventionNames":60},"Stage III, Arm II (DD-4A)","Patients able to undergo an upfront nephrectomy receive cycle 1 treatment of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, \\& 15 of cycle 1. Patients with adverse biology receive cycle 2 treatment of regimen DD-4A as in STAGE II FHWT Arm III above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":62,"type":10,"description":63,"interventionNames":64},"Stage III, Arm II-Upfront\u002FDelayed (DD-4A, UH-3)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above: Vincristine IV on days 1, 8, \\& 15 of cycles 1, 5, 7, 10, \\& 13, and days 1 \\& 8 of cycles 3, 4, 8, \\& 11, doxorubicin IV 3-15 minutes on day 1 of cycles 1, 5, 7, 10, \\& 13, cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1, 5, 7, 10, \\& 13, and days 1-4 of cycles 2, 6, 9, 12, \\& 14, carboplatin IV over 15-60 minutes on day 1 of cycles 2, 6, 9, 12, and 14, etoposide IV over 60-120 minutes on days 1-4 of cycles 2, 6, 9, 12, \\& 14, and irinotecan IV over 90 minutes on days 1-5 of cycles 3, 4, 8, \\& 11. Treatment repeats every 21 days for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[33,13,34,14,28,35,36,15,16,17,18],{"label":66,"type":10,"description":67,"interventionNames":68},"Stage III, Arm IIA (MVI)","Patients receive regimen MVI: Vincristine IV on days 1, 8, \\& 15 of cycle 3, days 8 \\& 15 of cycle 4, and day 1 of cycles 5 \\& 7-13, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 7, 9, 11, \\& 13, doxorubicin IV over 3-15 minutes on day 1 of cycles 3, 7, 9, 11, \\& 13, cyclophosphamide IV over 15-30 minutes daily on days 1-5 of cycles 4 and 6, irinotecan IV over 90 minutes daily on days 1-5 of cycles 5, 8, 10 \\& 12, and etoposide IV over 60-120 minutes daily on days 1-5 of cycles 4 and 6. Treatment repeats every 21 days for 11 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[69,13,34,14,28,35,36,15,70,16,17,18],"Procedure: Bone Scan","Procedure: Positron Emission Tomography",{"label":72,"type":10,"description":73,"interventionNames":74},"Stage III, Arm IIB (M)","Patients receive regimen M: Cyclophosphamide IV over 15-30 minutes daily on days 1-5 of cycles 3, 4, 7, \\& 9, etoposide IV over 60-120 minutes daily on days 1-5 of cycles 3, 4, 7, \\& 9, vincristine IV on days 8 \\& 15 of cycles 3 \\& 4 and day 1 of cycles 5, 6, 8, 10, \\& 11, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 5, 6, 8, 10, \\& 11, and doxorubicin IV over 3-15 minutes of cycles 5, 6, 8, 10, \\& 11.",[13,34,14,28,35,15,16,17,18],{"label":76,"type":10,"description":77,"interventionNames":78},"Stage III, Arm III-Upfront\u002FDelayed (DD-4A, MVI)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":80,"type":10,"description":81,"interventionNames":82},"Stage III, Arm IV-Upfront\u002FDelayed (DD-4A, M)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":84,"type":10,"description":85,"interventionNames":86},"Stage III, Arm IX-Upfront\u002FDelayed (MVI)","Patients receive cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":88,"type":10,"description":89,"interventionNames":90},"Stage III, Arm V-Upfront\u002FDelayed (DD-4A)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive cycles 3-4 of regimen DD-4A as in STAGE II FHWT Arm III above. They then undergo delayed nephrectomy after cycle 3 or 4. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,91,16,17,18],"Procedure: Nephrectomy",{"label":93,"type":10,"description":94,"interventionNames":95},"Stage III, Arm VA-Upfront\u002FDelayed (DD-4A)","Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen DD-4A as in STAGE II FHWT Arm III above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":97,"type":10,"description":98,"interventionNames":99},"Stage III, Arm VB-Upfront\u002FDelayed (M)","Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,18],{"label":101,"type":10,"description":102,"interventionNames":103},"Stage III, Arm VI-Upfront\u002FDelayed (DD-4A, MVI)","Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive cycles 3-4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":105,"type":10,"description":106,"interventionNames":107},"Stage III, Arm VII-Upfront\u002FDelayed (DD-4A, M)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":109,"type":10,"description":110,"interventionNames":111},"Stage III, Arm VIII-Upfront\u002FDelayed (UH-3)","Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[33,13,34,28,35,36,15,16,17,18],{"label":113,"type":10,"description":114,"interventionNames":115},"Stage III, Arm X-Upfront\u002FDelayed (M)","Patients receive cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":117,"type":10,"description":118,"interventionNames":119},"Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive cycles 3-9 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) Arms V and VA above.Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":121,"type":10,"description":122,"interventionNames":123},"Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[33,13,34,14,28,35,36,15,16,17,18],{"label":125,"type":10,"description":126,"interventionNames":127},"Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)","Patients in Stage IV Arm III Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":129,"type":10,"description":130,"interventionNames":131},"Stage IV Arm IV-Upfront-Delayed (DD-4A, M)","Patients in Stage IV Arm IV Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":133,"type":10,"description":134,"interventionNames":135},"Stage IV Arm IX-Upfront-Delayed (MVI)","Patients in Stage IV Arm IX Upfront-Delayed continue cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":137,"type":10,"description":138,"interventionNames":139},"Stage IV Arm V-Upfront-Delayed (DD-4A)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients continue with regimen DD4A for up to 4 cycles, until time of delayed nephrectomy after cycle 3 or 4 of regimen DD-4A as in STAGE II FHWT Arm II above. They then undergo delayed nephrectomy after cycle 3 or 4. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,91,16,17,18],{"label":141,"type":10,"description":142,"interventionNames":143},"Stage IV Arm VA-Upfront-Delayed (DD-4A)","Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen DD-4A as in STAGE II FHWT Arm II above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":145,"type":10,"description":146,"interventionNames":147},"Stage IV Arm VB-Upfront-Delayed (M)","Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":149,"type":10,"description":150,"interventionNames":151},"Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients continue with regimen MVI for up to 4 cycles, until time of delayed nephrectomy after cycles 3 or 4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[69,13,34,14,28,35,36,15,70,16,17,18],{"label":153,"type":10,"description":154,"interventionNames":155},"Stage IV Arm VII-Upfront-Delayed (DD-4A, M)","Patients in Stage IV Arm VII Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients continue with regimen M for up to 4 cycles, until time of delayed nephrectomy after cycles 3 or 4 of regimen M as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],{"label":157,"type":10,"description":158,"interventionNames":159},"Stage IV Arm VIII-Upfront-Delayed (UH-3)","Patients in Stage IV Arm VIII Upfront-Delayed receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[33,13,34,28,35,36,15,16,17,18],{"label":161,"type":10,"description":162,"interventionNames":163},"Stage IV Arm X-Upfront-Delayed (M)","Patients continue cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[69,13,34,14,28,35,15,70,16,17,18],{"label":165,"type":10,"description":166,"interventionNames":167},"Stage IV Extrapulmonary Arm I (DD-4A, MVI)","Patients in Stage IV Extrapulmonary Arm I receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,14,28,35,36,15,70,16,17,18],{"label":169,"type":10,"description":170,"interventionNames":171},"Stage IV Extrapulmonary Arm II (DD-4A, M)","Patients in Stage IV Extrapulmonary Arm II receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,14,28,35,15,70,16,17,18],{"label":173,"type":10,"description":174,"interventionNames":175},"Stage IV Extrapulmonary Arm III (DD-4A, MVI)","Patients in Stage IV Extrapulmonary Arm III receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,28,35,36,15,70,16,17,18],{"label":177,"type":10,"description":178,"interventionNames":179},"Stage IV Extrapulmonary Arm IV (DD-4A, M)","Patients in Stage IV Extrapulmonary Arm IV receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,14,28,35,15,70,16,17,18],{"label":181,"type":10,"description":182,"interventionNames":183},"Stage IV Extrapulmonary Arm IX (MVI)","Patients in Stage IV Extrapulmonary Arm IX receive cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,14,28,35,36,15,70,16,17,18],{"label":185,"type":10,"description":186,"interventionNames":187},"Stage IV Extrapulmonary Arm V (DD-4A, UH-3)","Patients in Stage IV Extrapulmonary Arm V receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,33,13,34,14,28,35,36,15,70,16,17,18],{"label":189,"type":10,"description":190,"interventionNames":191},"Stage IV Extrapulmonary Arm VI (DD-4A, MVI)","Patients in Stage IV Extrapulmonary Arm VI receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,14,28,35,36,15,70,16,17,18],{"label":193,"type":10,"description":194,"interventionNames":195},"Stage IV Extrapulmonary Arm VII (DD-4A, M)","Patients in Stage IV Extrapulmonary Arm VII receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,14,28,35,15,70,16,17,18],{"label":197,"type":10,"description":198,"interventionNames":199},"Stage IV Extrapulmonary Arm VIII (UH-3)","Patients in Stage IV Extrapulmonary Arm VIII receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,33,13,34,28,35,36,15,70,16,17,18],{"label":201,"type":10,"description":202,"interventionNames":203},"Stage IV Extrapulmonary Arm X (M)","Patients in Stage IV Extrapulmonary Arm X receive cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy may undergo bone scan and\u002For PET.",[69,13,34,28,35,15,70,16,17,18],{"label":205,"type":10,"description":206,"interventionNames":207},"Stage IV Lung Metastases Arm I (DD-4A)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients with standard biology and rapid complete lung response receive cycles 3-9 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) Arms V and VA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,14,28,15,16,17,18],{"label":209,"type":10,"description":210,"interventionNames":211},"Stage IV Lung Metastases Arm II (DD-4A, MVI)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,36,15,16,17,18],{"label":213,"type":10,"description":214,"interventionNames":215},"Stage IV Lung Metastases Arm III (DD-4A, M)","Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY\u002FDELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.",[13,34,14,28,35,15,16,17,18],[217,224,250,267,312,329,337,354,358,378,382,393,405,418,426],{"type":218,"name":219,"description":220,"armGroupLabels":221,"otherNames":222},"PROCEDURE","Bone Scan","Undergo bone scan for patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy",[66,149,161,165,169,173,177,181,185,189,193,197,201],[223],"Bone Scintigraphy",{"type":225,"name":226,"description":227,"armGroupLabels":228,"otherNames":229},"DRUG","Carboplatin","Given IV",[30,62,109,121,157,185,197],[230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":218,"name":251,"description":252,"armGroupLabels":253,"otherNames":254},"Computed Tomography","Undergo CT",[9,25,30,38,42,46,50,54,58,62,66,72,76,80,84,88,93,97,101,105,109,113,117,121,125,129,133,137,141,145,149,153,157,161,165,169,173,177,181,185,189,193,197,201,205,209,213],[255,256,257,258,259,260,261,262,263,264,265,266],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":225,"name":268,"description":227,"armGroupLabels":269,"otherNames":270},"Cyclophosphamide",[30,62,66,72,76,80,84,97,101,105,109,113,121,125,129,133,145,149,153,157,161,165,169,173,177,185,189,193,197,201,209,213],[271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Asta B 518","B 518","B-518","B518","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide 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MRI",{"type":218,"name":379,"description":380,"armGroupLabels":381,"otherNames":357},"Nephrectomy","Undergo nephrectomy",[88,137],{"type":383,"name":384,"description":385,"armGroupLabels":386,"otherNames":387},"OTHER","Patient Observation","Undergo observation after nephrectomy",[20],[388,389,390,391,392],"Active Surveillance","deferred therapy","expectant management","Observation","Watchful Waiting",{"type":218,"name":394,"description":395,"armGroupLabels":396,"otherNames":397},"Positron Emission Tomography","Undergo PET for patients with metastatic sites outside the chest\u002Fabdomen\u002Fpelvis documented during therapy",[66,149,161,165,169,173,177,181,185,189,193,197,201],[398,399,400,401,402,403,404],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":218,"name":406,"description":407,"armGroupLabels":408,"otherNames":409},"Ultrasound Imaging","Undergo ultrasound",[9,20,25,30,38,42,46,50,54,58,62,66,72,76,80,84,88,93,97,101,105,109,113,117,121,125,129,133,137,141,145,149,153,157,161,165,169,173,177,181,185,189,193,197,201,205,209,213],[410,411,412,413,414,415,416,417],"2-Dimensional Grayscale Ultrasound Imaging","2-Dimensional Ultrasound Imaging","2D-US","Ultrasonography","Ultrasound","Ultrasound Test","Ultrasound, Medical","US",{"type":225,"name":419,"description":227,"armGroupLabels":420,"otherNames":421},"Vincristine",[9,25,30,38,42,46,50,54,58,62,66,72,76,80,84,88,93,101,105,109,113,117,121,125,129,133,137,141,145,149,153,157,161,165,169,173,177,181,185,189,193,197,201,205,209,213],[422,423,424,425],"LCR","Leurocristine","VCR","Vincrystine",{"type":218,"name":427,"description":428,"armGroupLabels":429,"otherNames":430},"X-Ray Imaging","Undergo 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Mullen","PRINCIPAL_INVESTIGATOR",[446,467,481,497,512,526,541,556,570,584,599,614,629,641,656,671,685,699,713,729,744,759,774,790,806,820,835,850,865,877,891,902,917,926,940,955,970,984,1000,1015,1030,1045,1060,1076,1091,1102,1114,1128,1140,1154,1169,1185,1199,1215,1230,1242,1258,1273,1284,1296,1311,1322,1337,1352,1367,1380,1395,1407,1423,1434,1448,1463,1479,1494,1508,1520,1535,1546,1562,1578,1593,1607,1620,1636,1647,1662,1677,1692,1707,1721,1734,1745,1758,1772,1786,1800,1816,1830,1842,1856,1871,1885,1900,1915,1929,1943,1958,1974,1989,2001,2017,2031,2046,2061,2076,2091,2103,2119,2134,2148,2162,2176,2191,2206,2221,2235,2247,2262,2277,2292,2303,2318,2330,2341,2356,2372,2388,2403,2418,2433,2448,2463,2478,2493,2509,2524,2539,2556,2574,2589,2605,2621,2636,2650,2664,2679,2695,2707,2722],{"facility":447,"status":448,"city":449,"state":450,"zip":451,"country":452,"countryCode":417,"cosmosGeoPoint":453,"geoPoint":458,"contacts":459},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States",{"type":454,"coordinates":455},"Point",[456,457],-86.80249,33.52066,{"lat":457,"lon":456},[460,465],{"name":461,"role":462,"phone":463,"phoneExt":357,"email":464},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":466,"role":444,"phone":357,"phoneExt":357,"email":357},"Jamie M. Aye",{"facility":468,"status":448,"city":469,"state":450,"zip":470,"country":452,"countryCode":417,"cosmosGeoPoint":471,"geoPoint":475,"contacts":476},"USA Health Strada Patient Care Center","Mobile","36604",{"type":454,"coordinates":472},[473,474],-88.04305,30.69436,{"lat":474,"lon":473},[477,479],{"name":461,"role":462,"phone":478,"phoneExt":357,"email":357},"800-388-8721",{"name":480,"role":444,"phone":357,"phoneExt":357,"email":357},"Hamayun Imran",{"facility":482,"status":448,"city":483,"state":484,"zip":485,"country":452,"countryCode":417,"cosmosGeoPoint":486,"geoPoint":490,"contacts":491},"Providence Alaska Medical Center","Anchorage","Alaska","99508",{"type":454,"coordinates":487},[488,489],-149.90028,61.21806,{"lat":489,"lon":488},[492,495],{"name":461,"role":462,"phone":493,"phoneExt":357,"email":494},"907-212-6871","AKPAMC.OncologyResearchSupport@providence.org",{"name":496,"role":444,"phone":357,"phoneExt":357,"email":357},"Brenda J. Wittman",{"facility":498,"status":448,"city":499,"state":500,"zip":501,"country":452,"countryCode":417,"cosmosGeoPoint":502,"geoPoint":506,"contacts":507},"Banner Children's at Desert","Mesa","Arizona","85202",{"type":454,"coordinates":503},[504,505],-111.82264,33.42227,{"lat":505,"lon":504},[508,510],{"name":461,"role":462,"phone":509,"phoneExt":357,"email":357},"480-412-3100",{"name":511,"role":444,"phone":357,"phoneExt":357,"email":357},"Joseph C. Torkildson",{"facility":513,"status":448,"city":514,"state":500,"zip":515,"country":452,"countryCode":417,"cosmosGeoPoint":516,"geoPoint":520,"contacts":521},"Phoenix Childrens Hospital","Phoenix","85016",{"type":454,"coordinates":517},[518,519],-112.07404,33.44838,{"lat":519,"lon":518},[522,524],{"name":461,"role":462,"phone":523,"phoneExt":357,"email":357},"602-546-0920",{"name":525,"role":444,"phone":357,"phoneExt":357,"email":357},"Alok K. Kothari",{"facility":527,"status":448,"city":528,"state":529,"zip":530,"country":452,"countryCode":417,"cosmosGeoPoint":531,"geoPoint":535,"contacts":536},"Arkansas Children's Hospital","Little Rock","Arkansas","72202-3591",{"type":454,"coordinates":532},[533,534],-92.28959,34.74648,{"lat":534,"lon":533},[537,539],{"name":461,"role":462,"phone":538,"phoneExt":357,"email":357},"501-364-7373",{"name":540,"role":444,"phone":357,"phoneExt":357,"email":357},"Michael W. Bishop",{"facility":542,"status":448,"city":543,"state":544,"zip":545,"country":452,"countryCode":417,"cosmosGeoPoint":546,"geoPoint":550,"contacts":551},"Kaiser Permanente Downey Medical Center","Downey","California","90242",{"type":454,"coordinates":547},[548,549],-118.13257,33.94001,{"lat":549,"lon":548},[552,554],{"name":461,"role":462,"phone":553,"phoneExt":357,"email":357},"626-564-3455",{"name":555,"role":444,"phone":357,"phoneExt":357,"email":357},"Robert M. Cooper",{"facility":557,"status":448,"city":558,"state":544,"zip":559,"country":452,"countryCode":417,"cosmosGeoPoint":560,"geoPoint":564,"contacts":565},"Loma Linda University Medical Center","Loma Linda","92354",{"type":454,"coordinates":561},[562,563],-117.26115,34.04835,{"lat":563,"lon":562},[566,568],{"name":461,"role":462,"phone":567,"phoneExt":357,"email":357},"909-558-4050",{"name":569,"role":444,"phone":357,"phoneExt":357,"email":357},"Albert Kheradpour",{"facility":571,"status":448,"city":572,"state":544,"zip":573,"country":452,"countryCode":417,"cosmosGeoPoint":574,"geoPoint":578,"contacts":579},"Miller Children's and Women's Hospital Long Beach","Long Beach","90806",{"type":454,"coordinates":575},[576,577],-118.18923,33.76696,{"lat":577,"lon":576},[580,582],{"name":461,"role":462,"phone":581,"phoneExt":357,"email":357},"562-933-5600",{"name":583,"role":444,"phone":357,"phoneExt":357,"email":357},"Jacqueline N. Casillas",{"facility":585,"status":448,"city":586,"state":544,"zip":587,"country":452,"countryCode":417,"cosmosGeoPoint":588,"geoPoint":592,"contacts":593},"Cedars-Sinai Medical Center","Los Angeles","90048",{"type":454,"coordinates":589},[590,591],-118.24368,34.05223,{"lat":591,"lon":590},[594,597],{"name":461,"role":462,"phone":595,"phoneExt":357,"email":596},"310-423-2133","Cancer.trial.info@cshs.org",{"name":598,"role":444,"phone":357,"phoneExt":357,"email":357},"Leo Mascarenhas",{"facility":600,"status":448,"city":601,"state":544,"zip":602,"country":452,"countryCode":417,"cosmosGeoPoint":603,"geoPoint":607,"contacts":608},"Valley Children's Hospital","Madera","93636",{"type":454,"coordinates":604},[605,606],-120.06072,36.96134,{"lat":606,"lon":605},[609,612],{"name":461,"role":462,"phone":610,"phoneExt":357,"email":611},"559-353-3000","Research@valleychildrens.org",{"name":613,"role":444,"phone":357,"phoneExt":357,"email":357},"Ruetima Titapiwatanakun",{"facility":615,"status":448,"city":616,"state":544,"zip":617,"country":452,"countryCode":417,"cosmosGeoPoint":618,"geoPoint":622,"contacts":623},"UCSF Benioff Children's Hospital Oakland","Oakland","94609",{"type":454,"coordinates":619},[620,621],-122.2708,37.80437,{"lat":621,"lon":620},[624,627],{"name":461,"role":462,"phone":625,"phoneExt":357,"email":626},"510-428-3264","PedOncRschOAK@ucsf.edu",{"name":628,"role":444,"phone":357,"phoneExt":357,"email":357},"Natalie L. Wu",{"facility":630,"status":448,"city":616,"state":544,"zip":631,"country":452,"countryCode":417,"cosmosGeoPoint":632,"geoPoint":634,"contacts":635},"Kaiser Permanente-Oakland","94611",{"type":454,"coordinates":633},[620,621],{"lat":621,"lon":620},[636,639],{"name":461,"role":462,"phone":637,"phoneExt":357,"email":638},"877-642-4691","Kpoct@kp.org",{"name":640,"role":444,"phone":357,"phoneExt":357,"email":357},"Aarati V. Rao",{"facility":642,"status":448,"city":643,"state":544,"zip":644,"country":452,"countryCode":417,"cosmosGeoPoint":645,"geoPoint":649,"contacts":650},"Children's Hospital of Orange County","Orange","92868",{"type":454,"coordinates":646},[647,648],-117.85311,33.78779,{"lat":648,"lon":647},[651,654],{"name":461,"role":462,"phone":652,"phoneExt":357,"email":653},"714-509-8646","oncresearch@choc.org",{"name":655,"role":444,"phone":357,"phoneExt":357,"email":357},"Elyssa M. Rubin",{"facility":657,"status":448,"city":658,"state":544,"zip":659,"country":452,"countryCode":417,"cosmosGeoPoint":660,"geoPoint":664,"contacts":665},"Lucile Packard Children's Hospital Stanford University","Palo Alto","94304",{"type":454,"coordinates":661},[662,663],-122.14302,37.44188,{"lat":663,"lon":662},[666,669],{"name":461,"role":462,"phone":667,"phoneExt":357,"email":668},"800-694-0012","ccto-office@stanford.edu",{"name":670,"role":444,"phone":357,"phoneExt":357,"email":357},"Jay Michael S. Balagtas",{"facility":672,"status":448,"city":673,"state":544,"zip":674,"country":452,"countryCode":417,"cosmosGeoPoint":675,"geoPoint":679,"contacts":680},"University of California Davis Comprehensive Cancer Center","Sacramento","95817",{"type":454,"coordinates":676},[677,678],-121.4944,38.58157,{"lat":678,"lon":677},[681,683],{"name":461,"role":462,"phone":682,"phoneExt":357,"email":357},"916-734-3089",{"name":684,"role":444,"phone":357,"phoneExt":357,"email":357},"Marcio H. Malogolowkin",{"facility":686,"status":448,"city":687,"state":544,"zip":688,"country":452,"countryCode":417,"cosmosGeoPoint":689,"geoPoint":693,"contacts":694},"Rady Children's Hospital - San Diego","San Diego","92123",{"type":454,"coordinates":690},[691,692],-117.16472,32.71571,{"lat":692,"lon":691},[695,697],{"name":461,"role":462,"phone":696,"phoneExt":357,"email":357},"858-966-5934",{"name":698,"role":444,"phone":357,"phoneExt":357,"email":357},"William D. Roberts",{"facility":700,"status":448,"city":701,"state":544,"zip":702,"country":452,"countryCode":417,"cosmosGeoPoint":703,"geoPoint":707,"contacts":708},"UCSF Medical Center-Mission Bay","San Francisco","94158",{"type":454,"coordinates":704},[705,706],-122.41942,37.77493,{"lat":706,"lon":705},[709,712],{"name":461,"role":462,"phone":710,"phoneExt":357,"email":711},"877-827-3222","cancertrials@ucsf.edu",{"name":628,"role":444,"phone":357,"phoneExt":357,"email":357},{"facility":714,"status":448,"city":715,"state":716,"zip":717,"country":452,"countryCode":417,"cosmosGeoPoint":718,"geoPoint":722,"contacts":723},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":454,"coordinates":719},[720,721],-104.83192,39.72943,{"lat":721,"lon":720},[724,727],{"name":461,"role":462,"phone":725,"phoneExt":357,"email":726},"303-764-5056","josh.b.gordon@nsmtp.kp.org",{"name":728,"role":444,"phone":357,"phoneExt":357,"email":357},"Sandra Luna-Fineman",{"facility":730,"status":448,"city":731,"state":716,"zip":732,"country":452,"countryCode":417,"cosmosGeoPoint":733,"geoPoint":737,"contacts":738},"Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center","Denver","80218",{"type":454,"coordinates":734},[735,736],-104.9847,39.73915,{"lat":736,"lon":735},[739,742],{"name":461,"role":462,"phone":740,"phoneExt":357,"email":741},"303-832-2344","PSGResearchSharedMailbox@HCAHealthcare.com",{"name":743,"role":444,"phone":357,"phoneExt":357,"email":357},"Florence Choo",{"facility":745,"status":448,"city":746,"state":747,"zip":748,"country":452,"countryCode":417,"cosmosGeoPoint":749,"geoPoint":753,"contacts":754},"Connecticut Children's Medical Center","Hartford","Connecticut","06106",{"type":454,"coordinates":750},[751,752],-72.68509,41.76371,{"lat":752,"lon":751},[755,757],{"name":461,"role":462,"phone":756,"phoneExt":357,"email":357},"860-545-9981",{"name":758,"role":444,"phone":357,"phoneExt":357,"email":357},"Michael S. 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Lewis",{"facility":2575,"status":448,"city":2576,"state":2559,"zip":2577,"country":2561,"countryCode":2562,"cosmosGeoPoint":2578,"geoPoint":2582,"contacts":2583},"University of Alberta Hospital","Edmonton","T6G 2B7",{"type":454,"coordinates":2579},[2580,2581],-113.46871,53.55014,{"lat":2581,"lon":2580},[2584,2587],{"name":461,"role":462,"phone":2585,"phoneExt":357,"email":2586},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":2588,"role":444,"phone":357,"phoneExt":357,"email":357},"Sarah J. McKillop",{"facility":2590,"status":448,"city":2591,"state":2592,"zip":2593,"country":2561,"countryCode":2562,"cosmosGeoPoint":2594,"geoPoint":2598,"contacts":2599},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":454,"coordinates":2595},[2596,2597],-97.14704,49.8844,{"lat":2597,"lon":2596},[2600,2603],{"name":461,"role":462,"phone":2601,"phoneExt":357,"email":2602},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":2604,"role":444,"phone":357,"phoneExt":357,"email":357},"Stephanie M. Villeneuve",{"facility":2606,"status":448,"city":2607,"state":2608,"zip":2609,"country":2561,"countryCode":2562,"cosmosGeoPoint":2610,"geoPoint":2614,"contacts":2615},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":454,"coordinates":2611},[2612,2613],-63.57688,44.64269,{"lat":2613,"lon":2612},[2616,2619],{"name":461,"role":462,"phone":2617,"phoneExt":357,"email":2618},"902-470-8520","Research@iwk.nshealth.ca",{"name":2620,"role":444,"phone":357,"phoneExt":357,"email":357},"Craig Erker",{"facility":2622,"status":448,"city":2623,"state":2624,"zip":2625,"country":2561,"countryCode":2562,"cosmosGeoPoint":2626,"geoPoint":2630,"contacts":2631},"McMaster Children's Hospital at Hamilton Health Sciences","Hamilton","Ontario","L8N 3Z5",{"type":454,"coordinates":2627},[2628,2629],-79.84963,43.25011,{"lat":2629,"lon":2628},[2632,2634],{"name":461,"role":462,"phone":2633,"phoneExt":357,"email":357},"905-521-2100",{"name":2635,"role":444,"phone":357,"phoneExt":357,"email":357},"Uma H. Athale",{"facility":2637,"status":448,"city":2638,"state":2624,"zip":2639,"country":2561,"countryCode":2562,"cosmosGeoPoint":2640,"geoPoint":2644,"contacts":2645},"Children's Hospital","London","N6A 5W9",{"type":454,"coordinates":2641},[2642,2643],-81.23304,42.98339,{"lat":2643,"lon":2642},[2646,2648],{"name":461,"role":462,"phone":2647,"phoneExt":357,"email":357},"519-685-8306",{"name":2649,"role":444,"phone":357,"phoneExt":357,"email":357},"Shayna M. Zelcer",{"facility":2651,"status":448,"city":2652,"state":2624,"zip":2653,"country":2561,"countryCode":2562,"cosmosGeoPoint":2654,"geoPoint":2658,"contacts":2659},"Children's Hospital of Eastern Ontario","Ottawa","K1H 8L1",{"type":454,"coordinates":2655},[2656,2657],-75.69812,45.41117,{"lat":2657,"lon":2656},[2660,2662],{"name":461,"role":462,"phone":2661,"phoneExt":357,"email":357},"613-737-7600",{"name":2663,"role":444,"phone":357,"phoneExt":357,"email":357},"Donna L. Johnston",{"facility":2665,"status":448,"city":2666,"state":2624,"zip":2667,"country":2561,"countryCode":2562,"cosmosGeoPoint":2668,"geoPoint":2672,"contacts":2673},"Hospital for Sick Children","Toronto","M5G 1X8",{"type":454,"coordinates":2669},[2670,2671],-79.39864,43.70643,{"lat":2671,"lon":2670},[2674,2677],{"name":461,"role":462,"phone":2675,"phoneExt":357,"email":2676},"416-813-7654","ask.CRS@sickkids.ca",{"name":2678,"role":444,"phone":357,"phoneExt":357,"email":357},"Avram E. Denburg",{"facility":2680,"status":448,"city":2681,"state":2682,"zip":2683,"country":2561,"countryCode":2562,"cosmosGeoPoint":2684,"geoPoint":2688,"contacts":2689},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",{"type":454,"coordinates":2685},[2686,2687],-73.58781,45.50884,{"lat":2687,"lon":2686},[2690,2693],{"name":461,"role":462,"phone":2691,"phoneExt":357,"email":2692},"514-412-4445","info@thechildren.com",{"name":2694,"role":444,"phone":357,"phoneExt":357,"email":357},"Stephanie Mourad",{"facility":2696,"status":448,"city":2681,"state":2682,"zip":2697,"country":2561,"countryCode":2562,"cosmosGeoPoint":2698,"geoPoint":2700,"contacts":2701},"Centre Hospitalier Universitaire Sainte-Justine","H3T 1C5",{"type":454,"coordinates":2699},[2686,2687],{"lat":2687,"lon":2686},[2702,2705],{"name":461,"role":462,"phone":2703,"phoneExt":357,"email":2704},"514-345-4931","yvan.samson@umontreal.ca",{"name":2706,"role":444,"phone":357,"phoneExt":357,"email":357},"Monia Marzouki",{"facility":2708,"status":448,"city":2709,"state":2682,"zip":2710,"country":2561,"countryCode":2562,"cosmosGeoPoint":2711,"geoPoint":2715,"contacts":2716},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",{"type":454,"coordinates":2712},[2713,2714],-71.89908,45.40008,{"lat":2714,"lon":2713},[2717,2720],{"name":461,"role":462,"phone":2718,"phoneExt":357,"email":2719},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":2721,"role":444,"phone":357,"phoneExt":357,"email":357},"Josee Brossard",{"facility":2723,"status":448,"city":2724,"state":357,"zip":2725,"country":2561,"countryCode":2562,"cosmosGeoPoint":2726,"geoPoint":2730,"contacts":2731},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",{"type":454,"coordinates":2727},[2728,2729],-71.21454,46.81228,{"lat":2729,"lon":2728},[2732,2735],{"name":461,"role":462,"phone":2733,"phoneExt":357,"email":2734},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":2736,"role":444,"phone":357,"phoneExt":357,"email":357},"Bruno Michon",{"type":2738,"investigatorFullName":357,"investigatorTitle":357,"investigatorAffiliation":357,"oldNameTitle":357,"oldOrganization":357},"SPONSOR","100546927",false,"NCT06401330","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)","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.\n* Patients must be \\\u003C 30 years old at enrollment.\n* Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1.\n* 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.\n\n  * Patients must enroll on AREN2231 by Day 14.\n  * 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.\n* 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.\n\n  * 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.\n* 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.\n\n  * 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.\n* 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.\n* 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).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Aspartate aminotransferase (AST\u002Fserum glutamate oxaloacetic transaminase \\[SGOT\\]) OR alanine transaminase (ALT\u002Fserum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)\n\n  * 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.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patient with a diagnosis of Stage V Bilateral Wilms Tumor.\n* Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible.\n* Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.\n* Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and\u002For unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.\n\n  * Notes:\n\n    * 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.\n    * Exclusion from the Nephrectomy Only arm applies to two groups of patients:\n\n      * Patients \\\u003C 4 years with Stage I FHWT other than epithelial subtype AND\n      * Stage I patients of any age with Epithelial WT\n    * For the purpose of exclusion from the Nephrectomy Only Arm, known or suspected WT predisposition syndromes or conditions are defined as follows:\n\n      * WT Predisposition Syndromes: Beckwith Wiedemann Spectrum, Denys Drash, Trisomy 18, Idiopathic Hemihypertrophy\u002FIsolated Lateralized Overgrowth, WAGR, Simpson-Golabi-Behmel, Bohring-Opitz, or other conditions considered by treating physician to predispose to WT.\n      * WT Predisposing Conditions:\n\n        * A unilateral WT and (radiologic or pathologic) determination of contralateral nephrogenic rest(s) AND\u002FOR\n        * Unilateral multicentric WT\n* Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.\n* 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.\n\n  * 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.\n* Patients with known Charcot-Marie-Tooth syndrome.\n* 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.\n* Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.\n* Patients receiving concurrent chemotherapy for a different diagnosis.\n* 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.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.","ALL","30 Years",{"count":2748,"type":2749},1656,"ESTIMATED","INTERVENTIONAL",[2752],"PHASE3","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.",[2755,2756,2757,2758],"Stage I Mixed Cell Type Kidney Wilms Tumor","Stage II Mixed Cell Type Kidney Wilms Tumor","Stage III Mixed Cell Type Kidney Wilms Tumor","Stage IV Mixed Cell Type Kidney Wilms Tumor","2026-05-01",{"date":2761,"type":2762},"2026-05-05","ACTUAL",{"date":2764,"type":2762},"2025-04-15",{"date":2766,"type":2749},"2031-02-13",{"name":5,"class":6},159]