[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597706":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":60,"studyPopulation":56,"armGroups":61,"interventions":84,"overallOfficials":300,"centralContacts":56,"locations":305,"responsibleParty":4541,"collaborators":56,"id":4543,"slug":4544,"hasResults":4545,"nctId":4546,"briefTitle":4547,"officialTitle":4548,"acronym":56,"eligibilityCriteria":4549,"healthyVolunteers":4545,"sex":4550,"minAge":4551,"maxAge":56,"enrollmentInfo":4552,"targetDuration":56,"studyType":4555,"phases":4556,"briefSummary":4558,"conditions":4559,"keywords":56,"overallStatus":308,"whyStopped":56,"lastUpdateSubmitDate":4568,"lastUpdatePostDateStruct":4569,"startDateStruct":4572,"completionDateStruct":4574,"leadSponsor":4576,"locationsCount":4577},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Progression free survival (PFS)","Analysis will be performed using a one-sided log-rank test stratified by factors declared at randomization when (at least) 190 PFS events are observed in both arms. Patients will be grouped by their randomized treatment for intention-to-treat (ITT) analyses, supported by patients in ITT population. Treatment hazard ratio and confidence will be estimated using Cox proportional hazard models specified with a main effect for the randomized treatment assignment and stratified by factors declared at randomization. PFS at 2 years will be estimated using Kaplan-Meier method for each arm.","From randomization to time of progression or death from any cause, whichever occurs first, or date of last contact if neither progression nor death has occurred, up to 7 years",[14,18,22,26,30,34,38,42],{"measure":15,"description":16,"timeFrame":17},"Overall survival (OS)","The OS treatment hypothesis test (Arm 2 versus \\[vs.\\] Arm 1) will be based on a 1-sided log-rank test, stratified by the factors specified at randomization. Comparisons of the OS distributions by treatment arm will be described using Kaplan-Meier methods. Treatment hazard ratio estimates and their 95% confidence intervals will be estimated using a multivariable proportional hazards model specified with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.","From randomization to death from any cause, up to 7 years",{"measure":19,"description":20,"timeFrame":21},"Incidence of adverse events (AEs)","Assessed by Common Terminology Criteria for Adverse Events version 5.0. The nature, frequency, and degree of toxicity will be tabulated at the System Organ Class and AE-specific term levels. Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment. Differences in the level of toxicities by treatment arm will be assessed by classifying them as severe (grade 3 or higher) or not severe (grade 2 or lower) and examining the relative proportion of severe toxicities by Fisher's exact test.","Up to 7 years",{"measure":23,"description":24,"timeFrame":25},"Duration of concurrent chemoradiation therapy (CCRT) completion","Will be summarized and compared using 2-sample Wilcoxon rank sum tests. The proportion of patients with a delayed time to initiate CCRT by 2 weeks or more will be estimated and investigated by Fisher's exact test.","From CCRT start date to CCRT end date",{"measure":27,"description":28,"timeFrame":29},"Number of cycles of cisplatin","Will be summarized and compared using 2-sample Wilcoxon rank sum tests.","From 7 days after the last dose of induction chemotherapy to the CCRT start date for Arm 2, the planned CCRT start date to actual CCRT start date for Arm 1",{"measure":31,"description":32,"timeFrame":33},"Allostatic load","Will be summarized by treatment arm, and its association with OS will be evaluated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.","Up to 2 years",{"measure":35,"description":36,"timeFrame":37},"Tumor PD-L1 expression","The predictive value of tumor PD-L1 expression at baseline for PFS will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.","At baseline",{"measure":39,"description":40,"timeFrame":41},"Circulating tumor deoxyribonucleic acid expression","Will be summarized by treatment arm and by collection time. Will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.","At baseline and at 3 months post radiation therapy",{"measure":43,"description":44,"timeFrame":45},"Radiation quality pre-treatment score","Will be summarized by treatment arm, and its associations with PFS and OS will be evaluated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.","At time of radiation",[47,50],{"measure":48,"description":49,"timeFrame":21},"T cell receptor (TCR) expression","Will be summarized by treatment arm, and its correlation with PFS\u002FOS will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization. Repeated measure methods (e.g., linear mixed model) will be used for exploration of TCR evolution\u002Ftrajectory on treatment.",{"measure":51,"description":52,"timeFrame":37},"Tumor microenvironment","The predictive values of each of the pre-treatment tumor microenvironment biomarkers for PFS and OS will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":56,"timePerspective":56,"maskingInfo":58},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":59,"maskingDescription":56,"whoMasked":56},"NONE","PRIMARY OBJECTIVE:\n\nI. To determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiation therapy (CCRT) + IO improves progression-free survival (PFS) compared to CCRT+IO alone.\n\nSECONDARY OBJECTIVES:\n\nI. To assess whether induction IO and chemotherapy prior to CCRT+IO improves the overall survival (OS) compared to CCRT+IO alone.\n\nII. To determine the nature and degree of toxicity of induction IO and chemotherapy prior to CCRT + IO as compared to concurrent CCRT+IO as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.\n\nIII. To determine the impact on CCRT start, CCRT completion time, and number of cycles of cisplatin administered; with induction IO and chemotherapy prior to CCRT+IO arm as compared to CCRT+IO.\n\nIV. To assess the association between allostatic load and PFS\u002FOS. V. To assess the predictive value of the integrated biomarker: PD-L1 expression at baseline for progression free survival.\n\nVI. To assess the prognostic and predictive value of the integrated biomarker: circulating tumor deoxyribonucleic acid (ctDNA) at baseline and at 3 months post radiation therapy (RT) for progression free survival.\n\nVII. To explore radiotherapy quality pretreatment scores conducted by expert review with assistance from artificial intelligence (AI) models and correlation with outcomes.\n\nEXPLORATORY OBJECTIVES:\n\nI. To assess the evolution of T cell receptor (TCR) repertoire on treatment and its correlation with clinical outcomes.\n\nII. To identify pre-treatment tumor microenvironment biomarkers predictive of outcomes.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 1:\n\nCHEMORADIATION: Patients receive cisplatin intravenously (IV) once weekly (QW) for 5 weeks and pembrolizumab IV over 30 minutes every 3 weeks (Q3W) for 5 doses. Patients also undergo radiation therapy once daily 5 days per week for 25-29 treatments in weeks 1-5 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 5-7. Treatment is given in the absence of disease progression or unacceptable toxicity\n\nMAINTENANCE: Patients receive pembrolizumab IV over 30 minutes every 6 weeks (Q6W) for 15 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, chest x-ray and\u002For magnetic resonance imaging (MRI) and blood sample collection throughout the study.\n\nARM 2:\n\nINDUCTION: Patients receive carboplatin IV and paclitaxel IV QW on weeks 1-3 and pembrolizumab IV over 30 minutes Q3W on weeks 1 for each cycle. Cycles repeat every 3 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nCHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes every Q3W for 5 doses. Patients also undergo radiation therapy once daily 5 days per week for 25-29 treatments in weeks 7-11 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 11-13. Treatment is given in the absence of disease progression or unacceptable toxicity\n\nMAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo PET scan, CT scan, chest x-ray and\u002For MRI and blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for 3 years.",[62,77],{"label":63,"type":64,"description":65,"interventionNames":66},"Arm 1 (Standard care)","ACTIVE_COMPARATOR","CHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes Q3W for 5 doses. Patients also undergo radiation therapy with EBRT or IMRT once daily 5 days per week for 25-29 treatments in weeks 1-5 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 5-7. Treatment is given in the absence of disease progression or unacceptable toxicity\n\nMAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo PET scan, CT scan, chest x-ray and\u002For MRI and blood sample collection throughout the study.",[67,68,69,70,71,72,73,74,75,76],"Procedure: Biospecimen Collection","Radiation: Brachytherapy","Procedure: Chest Radiography","Drug: Cisplatin","Procedure: Computed Tomography","Radiation: External Beam Radiation Therapy","Radiation: Intensity-Modulated Radiation Therapy","Procedure: Magnetic Resonance Imaging","Biological: Pembrolizumab","Procedure: Positron Emission Tomography",{"label":78,"type":79,"description":80,"interventionNames":81},"Arm 2 (induction and standard care)","EXPERIMENTAL","INDUCTION: Patients receive carboplatin IV and paclitaxel IV QW on weeks 1-3 and pembrolizumab IV over 30 minutes Q3W on week 1 for each cycle. Cycles repeat every 3 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nCHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes every Q3W for 5 doses. Patients also undergo radiation therapy with EBRT or IMRT once daily 5 days per week for 25-29 treatments in weeks 7-11 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 11-13. Treatment is given in the absence of disease progression or unacceptable toxicity\n\nMAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo PET scan, CT scan, chest x-ray and\u002For MRI and blood sample collection throughout the study.",[67,68,82,69,70,71,72,73,74,83,75,76],"Drug: Carboplatin","Drug: Paclitaxel",[85,95,107,133,139,185,202,220,230,250,260,288],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[63,78],[91,92,93,94],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":100},"RADIATION","Brachytherapy","Undergo brachytherapy",[63,78],[101,102,103,104,105,106],"Brachytherapy, NOS","Internal Radiation","Internal Radiation Brachytherapy","Internal Radiation Therapy","Radiation Brachytherapy","Radiation, Internal",{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"DRUG","Carboplatin","Given IV",[78],[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":86,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"Chest Radiography","Undergo chest x-ray",[63,78],[138],"Chest X-ray",{"type":108,"name":140,"description":110,"armGroupLabels":141,"otherNames":142},"Cisplatin",[63,78],[143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin",{"type":86,"name":186,"description":187,"armGroupLabels":188,"otherNames":189},"Computed Tomography","Undergo CT scan",[63,78],[190,191,192,193,194,195,196,197,198,199,200,201],"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":96,"name":203,"description":204,"armGroupLabels":205,"otherNames":206},"External Beam Radiation Therapy","Undergo EBRT",[63,78],[207,208,209,210,211,212,213,214,215,216,217,218,219],"Definitive Radiation Therapy","EBRT","External Beam Radiation","External Beam Radiotherapy","External Beam Radiotherapy (conventional)","External Beam RT","external radiation","External Radiation Therapy","external-beam radiation","Radiation, External Beam","Teleradiotherapy","Teletherapy","Teletherapy Radiation",{"type":96,"name":221,"description":222,"armGroupLabels":223,"otherNames":224},"Intensity-Modulated Radiation Therapy","Undergo IMRT",[63,78],[225,226,227,228,229],"IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy",{"type":86,"name":231,"description":232,"armGroupLabels":233,"otherNames":234},"Magnetic Resonance Imaging","Undergo MRI",[63,78],[235,236,237,238,239,240,241,242,243,244,245,246,247,248,249],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":108,"name":251,"description":110,"armGroupLabels":252,"otherNames":253},"Paclitaxel",[78],[254,255,256,257,258,259],"Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol Konzentrat",{"type":261,"name":262,"description":110,"armGroupLabels":263,"otherNames":264},"BIOLOGICAL","Pembrolizumab",[63,78],[265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287],"BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","Pembrolizumab Biosimilar RPH-075","Pembrolizumab Biosimilar SB27","QL2107","RPH 075","RPH-075","RPH075","SB 27","SB-27","SB27","SCH 900475","SCH-900475","SCH900475",{"type":86,"name":289,"description":290,"armGroupLabels":291,"otherNames":292},"Positron Emission Tomography","Undergo PET scan",[63,78],[293,294,295,296,297,298,299],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",[301],{"name":302,"affiliation":303,"role":304},"Jyoti S Mayadev","NRG Oncology","PRINCIPAL_INVESTIGATOR",[306,327,343,357,370,382,398,413,426,438,453,463,471,486,496,508,517,529,541,553,568,580,592,604,616,628,643,655,670,684,700,714,722,734,749,761,773,786,801,816,824,836,847,855,870,879,891,906,920,933,945,960,974,984,992,1002,1014,1023,1031,1042,1054,1069,1081,1091,1105,1119,1135,1147,1159,1168,1180,1192,1206,1214,1223,1239,1251,1261,1276,1290,1298,1312,1325,1330,1344,1356,1368,1380,1394,1407,1419,1433,1442,1457,1470,1479,1490,1502,1514,1523,1539,1553,1566,1580,1593,1603,1615,1623,1636,1646,1658,1673,1687,1696,1708,1721,1729,1739,1747,1761,1773,1789,1801,1810,1822,1837,1853,1865,1873,1885,1897,1906,1920,1934,1947,1959,1974,1986,1999,2012,2026,2039,2053,2067,2083,2094,2109,2121,2133,2142,2154,2166,2180,2195,2203,2217,2229,2238,2250,2266,2278,2290,2298,2310,2324,2339,2351,2363,2379,2390,2399,2411,2425,2437,2450,2466,2475,2491,2505,2515,2524,2539,2555,2570,2584,2597,2610,2624,2636,2648,2661,2672,2687,2700,2716,2731,2746,2758,2772,2785,2797,2809,2821,2836,2850,2864,2874,2883,2892,2902,2910,2919,2934,2947,2960,2973,2987,3000,3008,3023,3031,3040,3052,3066,3082,3096,3108,3120,3134,3146,3158,3173,3185,3198,3212,3225,3234,3247,3258,3274,3288,3303,3315,3330,3342,3354,3369,3381,3390,3402,3415,3427,3439,3451,3466,3478,3490,3502,3518,3532,3542,3551,3560,3574,3580,3586,3598,3610,3623,3638,3649,3662,3671,3685,3698,3710,3721,3736,3749,3763,3778,3791,3806,3819,3832,3844,3857,3872,3883,3893,3906,3916,3926,3936,3948,3961,3973,3986,3999,4011,4026,4042,4057,4069,4081,4097,4113,4123,4135,4149,4165,4177,4186,4201,4216,4229,4238,4251,4265,4280,4293,4308,4321,4337,4351,4363,4375,4388,4396,4411,4420,4434,4448,4460,4473,4486,4500,4513,4529],{"facility":307,"status":308,"city":309,"state":310,"zip":311,"country":312,"countryCode":313,"cosmosGeoPoint":314,"geoPoint":319,"contacts":320},"University of Alabama at Birmingham Cancer Center","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":315,"coordinates":316},"Point",[317,318],-86.80249,33.52066,{"lat":318,"lon":317},[321,325],{"name":322,"role":323,"phone":56,"phoneExt":56,"email":324},"Site Public Contact","CONTACT","gingerreeves@uabmc.edu",{"name":326,"role":304,"phone":56,"phoneExt":56,"email":56},"Charles A. Leath",{"facility":328,"status":308,"city":329,"state":330,"zip":331,"country":312,"countryCode":313,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Highlands Oncology Group - Fayetteville","Fayetteville","Arkansas","72703",{"type":315,"coordinates":333},[334,335],-94.15743,36.06258,{"lat":335,"lon":334},[338,341],{"name":322,"role":323,"phone":339,"phoneExt":56,"email":340},"479-872-8100","research@hogonc.com",{"name":342,"role":304,"phone":56,"phoneExt":56,"email":56},"Joseph T. Beck",{"facility":344,"status":308,"city":345,"state":330,"zip":346,"country":312,"countryCode":313,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"University of Arkansas for Medical Sciences","Little Rock","72205",{"type":315,"coordinates":348},[349,350],-92.28959,34.74648,{"lat":350,"lon":349},[353,355],{"name":322,"role":323,"phone":354,"phoneExt":56,"email":56},"501-686-8274",{"name":356,"role":304,"phone":56,"phoneExt":56,"email":56},"Heather R. Williams",{"facility":358,"status":308,"city":359,"state":330,"zip":360,"country":312,"countryCode":313,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"Highlands Oncology Group - Rogers","Rogers","72758",{"type":315,"coordinates":362},[363,364],-94.11854,36.33202,{"lat":364,"lon":363},[367,369],{"name":322,"role":323,"phone":368,"phoneExt":56,"email":340},"479-872-8130",{"name":342,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":371,"status":308,"city":372,"state":330,"zip":373,"country":312,"countryCode":313,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Highlands Oncology Group","Springdale","72762",{"type":315,"coordinates":375},[376,377],-94.12881,36.18674,{"lat":377,"lon":376},[380,381],{"name":322,"role":323,"phone":368,"phoneExt":56,"email":340},{"name":342,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":383,"status":308,"city":384,"state":385,"zip":386,"country":312,"countryCode":313,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Kaiser Permanente-Bellflower","Bellflower","California","90706",{"type":315,"coordinates":388},[389,390],-118.11701,33.88168,{"lat":390,"lon":389},[393,396],{"name":322,"role":323,"phone":394,"phoneExt":56,"email":395},"800-398-3996","clinical.trials@kp.org",{"name":397,"role":304,"phone":56,"phoneExt":56,"email":56},"Devansu Tewari",{"facility":399,"status":308,"city":400,"state":385,"zip":401,"country":312,"countryCode":313,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"City of Hope Corona","Corona","92882",{"type":315,"coordinates":403},[404,405],-117.56644,33.87529,{"lat":405,"lon":404},[408,411],{"name":322,"role":323,"phone":409,"phoneExt":56,"email":410},"626-256-4673","becomingapatient@coh.org",{"name":412,"role":304,"phone":56,"phoneExt":56,"email":56},"Scott M. 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Barroilhet",{"facility":4412,"status":308,"city":4398,"state":4378,"zip":4413,"country":312,"countryCode":313,"cosmosGeoPoint":4414,"geoPoint":4416,"contacts":4417},"University of Wisconsin Carbone Cancer Center - University Hospital","53792",{"type":315,"coordinates":4415},[4402,4403],{"lat":4403,"lon":4402},[4418,4419],{"name":322,"role":323,"phone":4407,"phoneExt":56,"email":4408},{"name":4410,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4421,"status":308,"city":4422,"state":4378,"zip":4423,"country":312,"countryCode":313,"cosmosGeoPoint":4424,"geoPoint":4428,"contacts":4429},"Medical College of Wisconsin","Milwaukee","53226",{"type":315,"coordinates":4425},[4426,4427],-87.90647,43.0389,{"lat":4427,"lon":4426},[4430,4432],{"name":322,"role":323,"phone":4431,"phoneExt":56,"email":56},"414-805-3666",{"name":4433,"role":304,"phone":56,"phoneExt":56,"email":56},"William H. Bradley",{"facility":4435,"status":308,"city":4436,"state":4378,"zip":4437,"country":312,"countryCode":313,"cosmosGeoPoint":4438,"geoPoint":4442,"contacts":4443},"ProHealth D N Greenwald Center","Mukwonago","53149",{"type":315,"coordinates":4439},[4440,4441],-88.33343,42.86668,{"lat":4441,"lon":4440},[4444,4446],{"name":322,"role":323,"phone":56,"phoneExt":56,"email":4445},"research.institute@phci.org",{"name":4447,"role":304,"phone":56,"phoneExt":56,"email":56},"Timothy R. Wassenaar",{"facility":4449,"status":308,"city":4450,"state":4378,"zip":4451,"country":312,"countryCode":313,"cosmosGeoPoint":4452,"geoPoint":4456,"contacts":4457},"Cancer Center of Western Wisconsin","New Richmond","54017",{"type":315,"coordinates":4453},[4454,4455],-92.53659,45.12302,{"lat":4455,"lon":4454},[4458,4459],{"name":322,"role":323,"phone":2335,"phoneExt":56,"email":2336},{"name":2338,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4461,"status":308,"city":4462,"state":4378,"zip":4463,"country":312,"countryCode":313,"cosmosGeoPoint":4464,"geoPoint":4468,"contacts":4469},"ProHealth Oconomowoc Memorial Hospital","Oconomowoc","53066",{"type":315,"coordinates":4465},[4466,4467],-88.49927,43.11167,{"lat":4467,"lon":4466},[4470,4472],{"name":322,"role":323,"phone":4471,"phoneExt":56,"email":56},"262-928-7878",{"name":4447,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4474,"status":308,"city":4475,"state":4378,"zip":4476,"country":312,"countryCode":313,"cosmosGeoPoint":4477,"geoPoint":4481,"contacts":4482},"Essentia Health Saint Mary's Hospital - Superior","Superior","54880",{"type":315,"coordinates":4478},[4479,4480],-92.10408,46.72077,{"lat":4480,"lon":4479},[4483,4485],{"name":322,"role":323,"phone":4484,"phoneExt":56,"email":56},"701-364-6272",{"name":2265,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4487,"status":308,"city":4488,"state":4378,"zip":4489,"country":312,"countryCode":313,"cosmosGeoPoint":4490,"geoPoint":4494,"contacts":4495},"UW Cancer Center at ProHealth Care","Waukesha","53188",{"type":315,"coordinates":4491},[4492,4493],-88.23148,43.01168,{"lat":4493,"lon":4492},[4496,4499],{"name":322,"role":323,"phone":4497,"phoneExt":56,"email":4498},"262-928-5539","Chanda.miller@phci.org",{"name":4447,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4501,"status":308,"city":4502,"state":4503,"zip":4504,"country":312,"countryCode":313,"cosmosGeoPoint":4505,"geoPoint":4509,"contacts":4510},"Memorial Hospital of Laramie County","Cheyenne","Wyoming","82001",{"type":315,"coordinates":4506},[4507,4508],-104.82025,41.13998,{"lat":4508,"lon":4507},[4511,4512],{"name":322,"role":323,"phone":902,"phoneExt":56,"email":903},{"name":2465,"role":304,"phone":56,"phoneExt":56,"email":56},{"facility":4514,"status":308,"city":4515,"state":56,"zip":4516,"country":4517,"countryCode":4518,"cosmosGeoPoint":4519,"geoPoint":4523,"contacts":4524},"Doctors Cancer Center","Manati","00674","Puerto Rico","PR",{"type":315,"coordinates":4520},[4521,4522],-66.49212,18.42745,{"lat":4522,"lon":4521},[4525,4527],{"name":322,"role":323,"phone":4526,"phoneExt":56,"email":56},"787-621-4397",{"name":4528,"role":304,"phone":56,"phoneExt":56,"email":56},"Luis J. Santos Reyes",{"facility":4530,"status":308,"city":4531,"state":56,"zip":4532,"country":4517,"countryCode":4518,"cosmosGeoPoint":4533,"geoPoint":4537,"contacts":4538},"Centro Comprensivo de Cancer de UPR","San Juan","00927",{"type":315,"coordinates":4534},[4535,4536],-66.10572,18.46633,{"lat":4536,"lon":4535},[4539,4540],{"name":322,"role":323,"phone":902,"phoneExt":56,"email":903},{"name":4528,"role":304,"phone":56,"phoneExt":56,"email":56},{"type":4542,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100597706","phase-3-induction-pembrolizumab-and-chemotherapy-followed-by-pembrolizumab-before-chemoradiation-and-pembrolizumab-maintenance-compared-to-standard-chemoradiation-with-pembrolizumab-followed-by-pembrolizumab-maintenance-in-high-risk-cervical-cancer-100597706",false,"NCT07061977","Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer","A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:\n\n  * IIIA (T3aN0M0)\n  * IIIB (T3bN0M0)\n  * IIIC1(T3aN1M0, T3bN1M0)\n  * IIIC2 (T3aN2M0, T3bN2M0)\n  * IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.\n  * NOTE: prior partial\u002Fsubtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.\n\nNo paraaortic lymph node (PALN) metastases above the T12\u002FL1 interspace.\n\n* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET\u002FCT), fine needle aspirate\u002Fcore biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.\n\nRadiologic definition of lymph node staging:\n\n* N1:\n\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and\u002For\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET\n* N2:\n\n  * One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and\u002For\n  * One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET\n\n    * No prior definitive surgical, radiation, or systemic therapy for cervical cancer\n    * No prior immunotherapy\n    * No prior pelvic radiation therapy for any disease\n    * Age ≥ 18\n    * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n    * Not pregnant and not nursing\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n    * Platelets ≥ 100,000 cells\u002Fmm\\^3\n    * Hemoglobin ≥ 8 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobulin \\[Hgb\\] ≥ 8 g\u002Fdl is acceptable)\n    * Creatinine clearance (CrCL) of ≥ 50 mL\u002Fmin by the Cockcroft-Gault formula\n    * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n    * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n    * No active infection requiring parenteral antibiotics\n    * No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed\n    * No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration\n    * No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n    * No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n    * No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","FEMALE","18 Years",{"count":4553,"type":4554},336,"ESTIMATED","INTERVENTIONAL",[4557],"PHASE3","This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.",[4560,4561,4562,4563,4564,4565,4566,4567],"Locally Advanced Cervical Adenocarcinoma","Locally Advanced Cervical Adenosquamous Carcinoma","Locally Advanced Cervical Squamous Cell Carcinoma","Stage IIIA Cervical Cancer FIGO 2018","Stage IIIB Cervical Cancer FIGO 2018","Stage IIIC1 Cervical Cancer FIGO 2018","Stage IIIC2 Cervical Cancer FIGO 2018","Stage IVA Cervical Cancer FIGO 2018","2026-10-08",{"date":4570,"type":4571},"2026-10-09","ACTUAL",{"date":4573,"type":4571},"2025-11-05",{"date":4575,"type":4554},"2030-12-31",{"name":5,"class":6},339]