[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462662":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":171,"centralContacts":175,"locations":176,"responsibleParty":2721,"collaborators":2723,"id":2727,"slug":2728,"hasResults":2729,"nctId":2730,"briefTitle":2731,"officialTitle":2732,"acronym":175,"eligibilityCriteria":2733,"healthyVolunteers":2729,"sex":2734,"minAge":175,"maxAge":2735,"enrollmentInfo":2736,"targetDuration":175,"studyType":2739,"phases":2740,"briefSummary":2742,"conditions":2743,"keywords":175,"overallStatus":179,"whyStopped":175,"lastUpdateSubmitDate":2747,"lastUpdatePostDateStruct":2748,"startDateStruct":2751,"completionDateStruct":2753,"leadSponsor":2755,"locationsCount":2756},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Regimen M (positive mutation)","EXPERIMENTAL","Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.",[13,14,15,16,17,18,19,20,21],"Procedure: Biopsy Procedure","Procedure: Bone Scan","Procedure: Computed Tomography","Drug: Cyclophosphamide","Biological: Dactinomycin","Procedure: Magnetic Resonance Elastography","Procedure: Positron Emission Tomography","Radiation: Radiation Therapy","Drug: Vincristine",{"label":23,"type":10,"description":24,"interventionNames":25},"Regimen VA (VLR RMS)","Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.",[13,14,17,18,19,21],{"label":27,"type":10,"description":28,"interventionNames":29},"Regimen VAC\u002FVA (VL RMS)","Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Radiation therapy (if needed) will be administered at cycle 5.Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.",[13,14,15,16,17,18,19,21],[31,40,46,63,110,127,133,145,163],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Biopsy Procedure","Undergo tumor biopsy",[9,23,27],[37,38,39],"Biopsy","BIOPSY_TYPE","Bx",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Bone Scan","Undergo bone scan",[9,23,27],[45],"Bone Scintigraphy",{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Computed Tomography","Undergo CT scan",[9,27],[51,52,53,54,55,56,57,58,59,60,61,62],"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":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"DRUG","Cyclophosphamide","Given IV",[9,27],[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109],"(-)-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 Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR 138719","WR- 138719","WR-138719","WR138719",{"type":111,"name":112,"description":66,"armGroupLabels":113,"otherNames":114},"BIOLOGICAL","Dactinomycin",[9,23,27],[115,116,117,118,119,120,121,122,123,124,125,126],"Actinomycin A IV","Actinomycin C1","Actinomycin D","Actinomycin I1","Actinomycin IV","Actinomycin X 1","Actinomycin-[thr-val-pro-sar-meval]","Cosmegen","DACT","Dactinomycine","Lyovac Cosmegen","Meractinomycin",{"type":32,"name":128,"description":129,"armGroupLabels":130,"otherNames":131},"Magnetic Resonance Elastography","Undergo MRI",[9,23,27],[132],"MRE",{"type":32,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"Positron Emission Tomography","Undergo PET scan",[9,23,27],[138,139,140,141,142,143,144],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":146,"name":147,"description":148,"armGroupLabels":149,"otherNames":150},"RADIATION","Radiation Therapy","Undergo radiation",[9],[151,152,153,154,155,156,157,158,159,160,161,162],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":64,"name":164,"description":66,"armGroupLabels":165,"otherNames":166},"Vincristine",[9,23,27],[167,168,169,170],"LCR","Leurocristine","VCR","Vincrystine",[172],{"name":173,"affiliation":5,"role":174},"Josephine H Haduong","PRINCIPAL_INVESTIGATOR",null,[177,199,213,228,243,258,272,286,300,312,323,338,353,365,380,395,409,423,434,449,465,480,495,510,526,541,553,567,582,597,612,624,638,649,664,676,685,699,705,720,735,749,765,780,795,810,826,841,847,859,873,887,899,913,927,941,956,968,984,998,1014,1029,1044,1059,1071,1087,1102,1113,1125,1140,1151,1166,1181,1194,1209,1221,1235,1251,1262,1276,1291,1307,1321,1333,1344,1359,1370,1386,1395,1407,1423,1438,1452,1465,1479,1494,1510,1525,1540,1554,1567,1579,1591,1602,1615,1629,1644,1658,1674,1688,1700,1714,1729,1743,1759,1774,1789,1803,1815,1830,1844,1859,1875,1891,1907,1922,1936,1951,1962,1977,1992,2008,2020,2036,2051,2065,2079,2090,2106,2121,2135,2147,2162,2177,2192,2203,2218,2229,2244,2256,2267,2281,2296,2312,2327,2342,2357,2372,2387,2402,2417,2429,2444,2460,2475,2490,2507,2521,2535,2553,2568,2584,2600,2616,2632,2648,2660,2675,2690,2707],{"facility":178,"status":179,"city":180,"state":181,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":190,"contacts":191},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":186,"coordinates":187},"Point",[188,189],-86.80249,33.52066,{"lat":189,"lon":188},[192,197],{"name":193,"role":194,"phone":195,"phoneExt":175,"email":196},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":198,"role":174,"phone":175,"phoneExt":175,"email":175},"Jamie M. 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Casillas",{"facility":287,"status":179,"city":288,"state":246,"zip":289,"country":183,"countryCode":184,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Children's Hospital Los Angeles","Los Angeles","90027",{"type":186,"coordinates":291},[292,293],-118.24368,34.05223,{"lat":293,"lon":292},[296,298],{"name":193,"role":194,"phone":297,"phoneExt":175,"email":175},"323-361-4110",{"name":299,"role":174,"phone":175,"phoneExt":175,"email":175},"Sara Kreimer",{"facility":301,"status":179,"city":288,"state":246,"zip":302,"country":183,"countryCode":184,"cosmosGeoPoint":303,"geoPoint":305,"contacts":306},"Cedars-Sinai Medical Center","90048",{"type":186,"coordinates":304},[292,293],{"lat":293,"lon":292},[307,310],{"name":193,"role":194,"phone":308,"phoneExt":175,"email":309},"310-423-2133","Cancer.trial.info@cshs.org",{"name":311,"role":174,"phone":175,"phoneExt":175,"email":175},"Leo Mascarenhas",{"facility":313,"status":179,"city":288,"state":246,"zip":314,"country":183,"countryCode":184,"cosmosGeoPoint":315,"geoPoint":317,"contacts":318},"Mattel Children's Hospital UCLA","90095",{"type":186,"coordinates":316},[292,293],{"lat":293,"lon":292},[319,321],{"name":193,"role":194,"phone":320,"phoneExt":175,"email":175},"310-825-6708",{"name":322,"role":174,"phone":175,"phoneExt":175,"email":175},"Satiro N. De Oliveira",{"facility":324,"status":179,"city":325,"state":246,"zip":326,"country":183,"countryCode":184,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Valley Children's Hospital","Madera","93636",{"type":186,"coordinates":328},[329,330],-120.06072,36.96134,{"lat":330,"lon":329},[333,336],{"name":193,"role":194,"phone":334,"phoneExt":175,"email":335},"559-353-3000","Research@valleychildrens.org",{"name":337,"role":174,"phone":175,"phoneExt":175,"email":175},"Ruetima Titapiwatanakun",{"facility":339,"status":179,"city":340,"state":246,"zip":341,"country":183,"countryCode":184,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"UCSF Benioff Children's Hospital Oakland","Oakland","94609",{"type":186,"coordinates":343},[344,345],-122.2708,37.80437,{"lat":345,"lon":344},[348,351],{"name":193,"role":194,"phone":349,"phoneExt":175,"email":350},"510-428-3264","PedOncRschOAK@ucsf.edu",{"name":352,"role":174,"phone":175,"phoneExt":175,"email":175},"Jennifer G. Michlitsch",{"facility":354,"status":179,"city":340,"state":246,"zip":355,"country":183,"countryCode":184,"cosmosGeoPoint":356,"geoPoint":358,"contacts":359},"Kaiser Permanente-Oakland","94611",{"type":186,"coordinates":357},[344,345],{"lat":345,"lon":344},[360,363],{"name":193,"role":194,"phone":361,"phoneExt":175,"email":362},"877-642-4691","Kpoct@kp.org",{"name":364,"role":174,"phone":175,"phoneExt":175,"email":175},"Aarati V. Rao",{"facility":366,"status":179,"city":367,"state":246,"zip":368,"country":183,"countryCode":184,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Children's Hospital of Orange County","Orange","92868",{"type":186,"coordinates":370},[371,372],-117.85311,33.78779,{"lat":372,"lon":371},[375,378],{"name":193,"role":194,"phone":376,"phoneExt":175,"email":377},"714-509-8646","oncresearch@choc.org",{"name":379,"role":174,"phone":175,"phoneExt":175,"email":175},"Elyssa M. Rubin",{"facility":381,"status":179,"city":382,"state":246,"zip":383,"country":183,"countryCode":184,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"Lucile Packard Children's Hospital Stanford University","Palo Alto","94304",{"type":186,"coordinates":385},[386,387],-122.14302,37.44188,{"lat":387,"lon":386},[390,393],{"name":193,"role":194,"phone":391,"phoneExt":175,"email":392},"800-694-0012","ccto-office@stanford.edu",{"name":394,"role":174,"phone":175,"phoneExt":175,"email":175},"Jay Michael S. Balagtas",{"facility":396,"status":179,"city":397,"state":246,"zip":398,"country":183,"countryCode":184,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"University of California Davis Comprehensive Cancer Center","Sacramento","95817",{"type":186,"coordinates":400},[401,402],-121.4944,38.58157,{"lat":402,"lon":401},[405,407],{"name":193,"role":194,"phone":406,"phoneExt":175,"email":175},"916-734-3089",{"name":408,"role":174,"phone":175,"phoneExt":175,"email":175},"Marcio H. 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McGregor",{"facility":2282,"status":179,"city":2283,"state":2284,"zip":2285,"country":183,"countryCode":184,"cosmosGeoPoint":2286,"geoPoint":2290,"contacts":2291},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":186,"coordinates":2287},[2288,2289],-111.89105,40.76078,{"lat":2289,"lon":2288},[2292,2294],{"name":193,"role":194,"phone":2293,"phoneExt":175,"email":175},"801-585-5270",{"name":2295,"role":174,"phone":175,"phoneExt":175,"email":175},"Matthew Dietz",{"facility":2297,"status":179,"city":2298,"state":2299,"zip":2300,"country":183,"countryCode":184,"cosmosGeoPoint":2301,"geoPoint":2305,"contacts":2306},"University of Virginia Cancer Center","Charlottesville","Virginia","22908",{"type":186,"coordinates":2302},[2303,2304],-78.47668,38.02931,{"lat":2304,"lon":2303},[2307,2310],{"name":193,"role":194,"phone":2308,"phoneExt":175,"email":2309},"434-243-6303","uvacancertrials@hscmail.mcc.virginia.edu",{"name":2311,"role":174,"phone":175,"phoneExt":175,"email":175},"Brian C. Belyea",{"facility":2313,"status":179,"city":2314,"state":2299,"zip":2315,"country":183,"countryCode":184,"cosmosGeoPoint":2316,"geoPoint":2320,"contacts":2321},"Inova Fairfax Hospital","Falls Church","22042",{"type":186,"coordinates":2317},[2318,2319],-77.17109,38.88233,{"lat":2319,"lon":2318},[2322,2325],{"name":193,"role":194,"phone":2323,"phoneExt":175,"email":2324},"703-208-6650","Stephanie.VanBebber@inova.org",{"name":2326,"role":174,"phone":175,"phoneExt":175,"email":175},"Robin Y. Dulman",{"facility":2328,"status":179,"city":2329,"state":2299,"zip":2330,"country":183,"countryCode":184,"cosmosGeoPoint":2331,"geoPoint":2335,"contacts":2336},"Children's Hospital of The King's Daughters","Norfolk","23507",{"type":186,"coordinates":2332},[2333,2334],-76.28522,36.84681,{"lat":2334,"lon":2333},[2337,2340],{"name":193,"role":194,"phone":2338,"phoneExt":175,"email":2339},"757-668-7243","CCBDCresearch@chkd.org",{"name":2341,"role":174,"phone":175,"phoneExt":175,"email":175},"Melissa S. Mark",{"facility":2343,"status":179,"city":2344,"state":2299,"zip":2345,"country":183,"countryCode":184,"cosmosGeoPoint":2346,"geoPoint":2350,"contacts":2351},"VCU Massey Comprehensive Cancer Center","Richmond","23298",{"type":186,"coordinates":2347},[2348,2349],-77.46026,37.55376,{"lat":2349,"lon":2348},[2352,2355],{"name":193,"role":194,"phone":2353,"phoneExt":175,"email":2354},"804-628-6430","CTOclinops@vcu.edu",{"name":2356,"role":174,"phone":175,"phoneExt":175,"email":175},"Frances Austin",{"facility":2358,"status":179,"city":2359,"state":2299,"zip":2360,"country":183,"countryCode":184,"cosmosGeoPoint":2361,"geoPoint":2365,"contacts":2366},"Carilion Children's","Roanoke","24014",{"type":186,"coordinates":2362},[2363,2364],-79.94143,37.27097,{"lat":2364,"lon":2363},[2367,2370],{"name":193,"role":194,"phone":2368,"phoneExt":175,"email":2369},"540-266-6238","wpmccarty@carilionclinic.org",{"name":2371,"role":174,"phone":175,"phoneExt":175,"email":175},"Erwood G. Edwards",{"facility":2373,"status":179,"city":2374,"state":2375,"zip":2376,"country":183,"countryCode":184,"cosmosGeoPoint":2377,"geoPoint":2381,"contacts":2382},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":186,"coordinates":2378},[2379,2380],-122.33207,47.60621,{"lat":2380,"lon":2379},[2383,2385],{"name":193,"role":194,"phone":2384,"phoneExt":175,"email":175},"866-987-2000",{"name":2386,"role":174,"phone":175,"phoneExt":175,"email":175},"Sarah E. Leary",{"facility":2388,"status":179,"city":2389,"state":2375,"zip":2390,"country":183,"countryCode":184,"cosmosGeoPoint":2391,"geoPoint":2395,"contacts":2396},"Providence Sacred Heart Medical Center and Children's Hospital","Spokane","99204",{"type":186,"coordinates":2392},[2393,2394],-117.42908,47.65966,{"lat":2394,"lon":2393},[2397,2400],{"name":193,"role":194,"phone":2398,"phoneExt":175,"email":2399},"800-228-6618","HopeBeginsHere@providence.org",{"name":2401,"role":174,"phone":175,"phoneExt":175,"email":175},"Judy L. Felgenhauer",{"facility":2403,"status":179,"city":2404,"state":2375,"zip":2405,"country":183,"countryCode":184,"cosmosGeoPoint":2406,"geoPoint":2410,"contacts":2411},"Mary Bridge Children's Hospital and Health Center","Tacoma","98405",{"type":186,"coordinates":2407},[2408,2409],-122.44429,47.25288,{"lat":2409,"lon":2408},[2412,2415],{"name":193,"role":194,"phone":2413,"phoneExt":175,"email":2414},"253-403-1461","research@multicare.org",{"name":2416,"role":174,"phone":175,"phoneExt":175,"email":175},"Robert G. Irwin",{"facility":2418,"status":179,"city":2404,"state":2375,"zip":2419,"country":183,"countryCode":184,"cosmosGeoPoint":2420,"geoPoint":2422,"contacts":2423},"Madigan Army Medical Center","98431",{"type":186,"coordinates":2421},[2408,2409],{"lat":2409,"lon":2408},[2424,2427],{"name":193,"role":194,"phone":2425,"phoneExt":175,"email":2426},"253-968-6144","melissa.a.forouhar.mil@health.mil",{"name":2428,"role":174,"phone":175,"phoneExt":175,"email":175},"Melissa A. Forouhar",{"facility":2430,"status":179,"city":2431,"state":2432,"zip":2433,"country":183,"countryCode":184,"cosmosGeoPoint":2434,"geoPoint":2438,"contacts":2439},"West Virginia University Charleston Division","Charleston","West Virginia","25304",{"type":186,"coordinates":2435},[2436,2437],-81.63262,38.34982,{"lat":2437,"lon":2436},[2440,2442],{"name":193,"role":194,"phone":2441,"phoneExt":175,"email":175},"304-388-9944",{"name":2443,"role":174,"phone":175,"phoneExt":175,"email":175},"Mohamad H. Badawi",{"facility":2445,"status":179,"city":2446,"state":2447,"zip":2448,"country":183,"countryCode":184,"cosmosGeoPoint":2449,"geoPoint":2453,"contacts":2454},"University of Wisconsin Carbone Cancer Center - University Hospital","Madison","Wisconsin","53792",{"type":186,"coordinates":2450},[2451,2452],-89.40123,43.07305,{"lat":2452,"lon":2451},[2455,2458],{"name":193,"role":194,"phone":2456,"phoneExt":175,"email":2457},"800-622-8922","clinicaltrials@cancer.wisc.edu",{"name":2459,"role":174,"phone":175,"phoneExt":175,"email":175},"Margo L. Hoover-Regan",{"facility":2461,"status":179,"city":2462,"state":2447,"zip":2463,"country":183,"countryCode":184,"cosmosGeoPoint":2464,"geoPoint":2468,"contacts":2469},"Marshfield Medical Center-Marshfield","Marshfield","54449",{"type":186,"coordinates":2465},[2466,2467],-90.1718,44.66885,{"lat":2467,"lon":2466},[2470,2473],{"name":193,"role":194,"phone":2471,"phoneExt":175,"email":2472},"800-782-8581","oncology.clinical.trials@marshfieldresearch.org",{"name":2474,"role":174,"phone":175,"phoneExt":175,"email":175},"Michelle A. Manalang",{"facility":2476,"status":179,"city":2477,"state":2447,"zip":2478,"country":183,"countryCode":184,"cosmosGeoPoint":2479,"geoPoint":2483,"contacts":2484},"Children's Hospital of Wisconsin","Milwaukee","53226",{"type":186,"coordinates":2480},[2481,2482],-87.90647,43.0389,{"lat":2482,"lon":2481},[2485,2488],{"name":193,"role":194,"phone":2486,"phoneExt":175,"email":2487},"414-955-4727","MACCCTO@mcw.edu",{"name":2489,"role":174,"phone":175,"phoneExt":175,"email":175},"Kerri Becktell",{"facility":2491,"status":179,"city":2492,"state":2493,"zip":2494,"country":2495,"countryCode":2496,"cosmosGeoPoint":2497,"geoPoint":2501,"contacts":2502},"Sydney Children's Hospital","Randwick","New South Wales","2031","Australia","AU",{"type":186,"coordinates":2498},[2499,2500],151.24895,-33.91439,{"lat":2500,"lon":2499},[2503,2505],{"name":193,"role":194,"phone":2504,"phoneExt":175,"email":175},"(02) 9382-1721",{"name":2506,"role":174,"phone":175,"phoneExt":175,"email":175},"Draga Barbaric",{"facility":2508,"status":179,"city":2509,"state":2493,"zip":2510,"country":2495,"countryCode":2496,"cosmosGeoPoint":2511,"geoPoint":2515,"contacts":2516},"The Children's Hospital at Westmead","Westmead","2145",{"type":186,"coordinates":2512},[2513,2514],150.98768,-33.80383,{"lat":2514,"lon":2513},[2517,2519],{"name":193,"role":194,"phone":2518,"phoneExt":175,"email":175},"61-2-9845 1400",{"name":2520,"role":174,"phone":175,"phoneExt":175,"email":175},"Bhavna Padhye",{"facility":2522,"status":179,"city":2523,"state":2524,"zip":2525,"country":2495,"countryCode":2496,"cosmosGeoPoint":2526,"geoPoint":2530,"contacts":2531},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":186,"coordinates":2527},[2528,2529],115.8614,-31.95224,{"lat":2529,"lon":2528},[2532,2533],{"name":193,"role":194,"phone":175,"phoneExt":175,"email":696},{"name":2534,"role":174,"phone":175,"phoneExt":175,"email":175},"Marianne B. Phillips",{"facility":2536,"status":179,"city":2537,"state":2538,"zip":2539,"country":2540,"countryCode":2541,"cosmosGeoPoint":2542,"geoPoint":2546,"contacts":2547},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":186,"coordinates":2543},[2544,2545],-114.08529,51.05011,{"lat":2545,"lon":2544},[2548,2551],{"name":193,"role":194,"phone":2549,"phoneExt":175,"email":2550},"403-220-6898","research4kids@ucalgary.ca",{"name":2552,"role":174,"phone":175,"phoneExt":175,"email":175},"Victor A. Lewis",{"facility":2554,"status":179,"city":2555,"state":2538,"zip":2556,"country":2540,"countryCode":2541,"cosmosGeoPoint":2557,"geoPoint":2561,"contacts":2562},"University of Alberta Hospital","Edmonton","T6G 2B7",{"type":186,"coordinates":2558},[2559,2560],-113.46871,53.55014,{"lat":2560,"lon":2559},[2563,2566],{"name":193,"role":194,"phone":2564,"phoneExt":175,"email":2565},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":2567,"role":174,"phone":175,"phoneExt":175,"email":175},"Sarah J. McKillop",{"facility":2569,"status":179,"city":2570,"state":2571,"zip":2572,"country":2540,"countryCode":2541,"cosmosGeoPoint":2573,"geoPoint":2577,"contacts":2578},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":186,"coordinates":2574},[2575,2576],-123.11934,49.24966,{"lat":2576,"lon":2575},[2579,2582],{"name":193,"role":194,"phone":2580,"phoneExt":2581,"email":175},"604-875-2345","6477",{"name":2583,"role":174,"phone":175,"phoneExt":175,"email":175},"Rebecca J. Deyell",{"facility":2585,"status":179,"city":2586,"state":2587,"zip":2588,"country":2540,"countryCode":2541,"cosmosGeoPoint":2589,"geoPoint":2593,"contacts":2594},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":186,"coordinates":2590},[2591,2592],-97.14704,49.8844,{"lat":2592,"lon":2591},[2595,2598],{"name":193,"role":194,"phone":2596,"phoneExt":175,"email":2597},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":2599,"role":174,"phone":175,"phoneExt":175,"email":175},"Stephanie M. Villeneuve",{"facility":2601,"status":179,"city":2602,"state":2603,"zip":2604,"country":2540,"countryCode":2541,"cosmosGeoPoint":2605,"geoPoint":2609,"contacts":2610},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":186,"coordinates":2606},[2607,2608],-63.57688,44.64269,{"lat":2608,"lon":2607},[2611,2614],{"name":193,"role":194,"phone":2612,"phoneExt":175,"email":2613},"902-470-8520","Research@iwk.nshealth.ca",{"name":2615,"role":174,"phone":175,"phoneExt":175,"email":175},"Craig Erker",{"facility":2617,"status":179,"city":2618,"state":2619,"zip":2620,"country":2540,"countryCode":2541,"cosmosGeoPoint":2621,"geoPoint":2625,"contacts":2626},"Hospital for Sick Children","Toronto","Ontario","M5G 1X8",{"type":186,"coordinates":2622},[2623,2624],-79.39864,43.70643,{"lat":2624,"lon":2623},[2627,2630],{"name":193,"role":194,"phone":2628,"phoneExt":175,"email":2629},"416-813-7654","ask.CRS@sickkids.ca",{"name":2631,"role":174,"phone":175,"phoneExt":175,"email":175},"Anita Villani",{"facility":2633,"status":179,"city":2634,"state":2635,"zip":2636,"country":2540,"countryCode":2541,"cosmosGeoPoint":2637,"geoPoint":2641,"contacts":2642},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",{"type":186,"coordinates":2638},[2639,2640],-73.58781,45.50884,{"lat":2640,"lon":2639},[2643,2646],{"name":193,"role":194,"phone":2644,"phoneExt":175,"email":2645},"514-412-4445","info@thechildren.com",{"name":2647,"role":174,"phone":175,"phoneExt":175,"email":175},"Stephanie Mourad",{"facility":2649,"status":179,"city":2634,"state":2635,"zip":2650,"country":2540,"countryCode":2541,"cosmosGeoPoint":2651,"geoPoint":2653,"contacts":2654},"Centre Hospitalier Universitaire Sainte-Justine","H3T 1C5",{"type":186,"coordinates":2652},[2639,2640],{"lat":2640,"lon":2639},[2655,2658],{"name":193,"role":194,"phone":2656,"phoneExt":175,"email":2657},"514-345-4931","yvan.samson@umontreal.ca",{"name":2659,"role":174,"phone":175,"phoneExt":175,"email":175},"Monia Marzouki",{"facility":2661,"status":179,"city":2662,"state":2635,"zip":2663,"country":2540,"countryCode":2541,"cosmosGeoPoint":2664,"geoPoint":2668,"contacts":2669},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",{"type":186,"coordinates":2665},[2666,2667],-71.89908,45.40008,{"lat":2667,"lon":2666},[2670,2673],{"name":193,"role":194,"phone":2671,"phoneExt":175,"email":2672},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":2674,"role":174,"phone":175,"phoneExt":175,"email":175},"Josee Brossard",{"facility":2676,"status":179,"city":2677,"state":175,"zip":2678,"country":2540,"countryCode":2541,"cosmosGeoPoint":2679,"geoPoint":2683,"contacts":2684},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",{"type":186,"coordinates":2680},[2681,2682],-71.21454,46.81228,{"lat":2682,"lon":2681},[2685,2688],{"name":193,"role":194,"phone":2686,"phoneExt":175,"email":2687},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":2689,"role":174,"phone":175,"phoneExt":175,"email":175},"Bruno Michon",{"facility":2691,"status":179,"city":2692,"state":2693,"zip":2694,"country":2695,"countryCode":2696,"cosmosGeoPoint":2697,"geoPoint":2701,"contacts":2702},"Starship Children's Hospital","Grafton","Auckland","1145","New Zealand","NZ",{"type":186,"coordinates":2698},[2699,2700],174.76566,-36.86029,{"lat":2700,"lon":2699},[2703,2705],{"name":193,"role":194,"phone":2704,"phoneExt":175,"email":175},"0800 728 436",{"name":2706,"role":174,"phone":175,"phoneExt":175,"email":175},"Mandy PohLui de Silva",{"facility":2708,"status":179,"city":2709,"state":175,"zip":2710,"country":2695,"countryCode":2696,"cosmosGeoPoint":2711,"geoPoint":2715,"contacts":2716},"Christchurch Hospital","Christchurch","8011",{"type":186,"coordinates":2712},[2713,2714],172.63333,-43.53333,{"lat":2714,"lon":2713},[2717,2719],{"name":193,"role":194,"phone":2718,"phoneExt":175,"email":175},"03 364 0640",{"name":2720,"role":174,"phone":175,"phoneExt":175,"email":175},"Tristan Pettit",{"type":2722,"investigatorFullName":175,"investigatorTitle":175,"investigatorAffiliation":175,"oldNameTitle":175,"oldOrganization":175},"SPONSOR",[2724],{"name":2725,"class":2726},"National Cancer Institute (NCI)","NIH","100462662","phase-3-chemotherapy-for-the-treatment-of-patients-with-newly-diagnosed-very-low-risk-and-low-risk-fusion-negative-rhabdomyosarcoma-100462662",false,"NCT05304585","Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma","A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).\n* Patients must be =\\\u003C 21 years at the time of enrollment.\n* Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell\u002Fsclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.\n\n  * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.\n\n    * Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.\n    * Patients will be eligible for the low-risk stratum (Regimen VAC\u002FVA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.\n  * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \\>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.\n  * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.\n  * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.\n* Patients must have a Lansky (for patients =\\\u003C 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of \\>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (within 7 days prior to enrollment).\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (within 7 days prior to enrollment).\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine (within 7 days prior to enrollment) based on age\u002Fgender as follows:\n\n  * Age: 1 month to \\\u003C 6 months; Maximum serum creatinine (mg\u002FdL): 0.4 (male) : 0.4 (female)\n  * Age: 6 months to \\\u003C 1 year; Maximum serum creatinine (mg\u002FdL): 0.5 (male) : 0.5 (female)\n  * Age: 1 to \\\u003C 2 years; Maximum serum creatinine (mg\u002FdL): 0.6 (male) : 0.6 (female)\n  * Age: 2 to \\\u003C 6 years; Maximum serum creatinine (mg\u002FdL): 0.8 (male) : 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; Maximum serum creatinine (mg\u002FdL): 1 (male) : 1 (female)\n  * Age: 10 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male) : 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male) : 1.4 (female)\n  * Age \\>= 16 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male) : 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age.\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\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* Patients who have received prior chemotherapy and\u002For radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.\n* Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.\n* Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.\n* Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.\n* Evidence of uncontrolled infection.\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","21 Years",{"count":2737,"type":2738},205,"ESTIMATED","INTERVENTIONAL",[2741],"PHASE3","Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.",[2744,2745,2746],"Embryonal Rhabdomyosarcoma","Fusion-Negative Alveolar Rhabdomyosarcoma","Spindle Cell\u002FSclerosing Rhabdomyosarcoma","2026-05-01",{"date":2749,"type":2750},"2026-05-05","ACTUAL",{"date":2752,"type":2750},"2022-08-04",{"date":2754,"type":2738},"2030-06-30",{"name":5,"class":6},180]