[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587296":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":127,"collaborators":25,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":25,"enrollmentInfo":141,"targetDuration":25,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Standard Arm","ACTIVE_COMPARATOR","Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy",[13],"Drug: Chemoradiation",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: Experimental arm","EXPERIMENTAL","Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Chemoradiation","This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Tabassum Wadasadawala, MD, DNB Radiotherapy","CONTACT","(+91-22) 24177026","7026","drtabs.radonc@gmail.com",[37,52,85,96,111],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":45},"Homi Bhabha Cancer Hospital & Research Centre","NOT_YET_RECRUITING","Vishkhapatnam","Andhra Pradesh","530053","India","IN",[46,50],{"name":47,"role":32,"phone":48,"phoneExt":25,"email":49},"Rohit Vadgaonkar","+910167 224 1241","dr.ravad@gmail.com",{"name":47,"role":51,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Mumbai","Maharasthra","400012",{"type":58,"coordinates":59},"Point",[60,61],72.88261,19.07283,{"lat":61,"lon":60},[64,66,68,71,73,75,77,79,81,83],{"name":65,"role":32,"phone":33,"phoneExt":25,"email":35},"Tabassum Wadasadawala",{"name":67,"role":51,"phone":25,"phoneExt":25,"email":25},"Tabassum Wadasadawala, MD, DNB (Radiotherapy)",{"name":69,"role":70,"phone":25,"phoneExt":25,"email":25},"Rajiv Sarin, MD, DNB (Radiation oncology)","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":25,"phoneExt":25,"email":25},"Rima Pathak, MD (Radiotherapy)",{"name":74,"role":70,"phone":25,"phoneExt":25,"email":25},"Revathy Krishnamurthy, MD (Radiotherapy)",{"name":76,"role":70,"phone":25,"phoneExt":25,"email":25},"Sudeep Gupta, MD, DM (Medical oncology)",{"name":78,"role":70,"phone":25,"phoneExt":25,"email":25},"Seema Gulia, MD, DM (Medical oncology)",{"name":80,"role":70,"phone":25,"phoneExt":25,"email":25},"Sushmita Rath, MD, DM (Medical oncology)",{"name":82,"role":70,"phone":25,"phoneExt":25,"email":25},"Shalaka Joshi, MS, DNB (General Surgery)",{"name":84,"role":70,"phone":25,"phoneExt":25,"email":25},"Anuradha Daptardar, Bsc (Physiotherapy)",{"facility":86,"status":39,"city":87,"state":88,"zip":89,"country":43,"countryCode":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":90},"Homi Bhabha Cancer Hospital and Research Centre","New Chandigarh","Punjab","140901",[91,95],{"name":92,"role":32,"phone":93,"phoneExt":25,"email":94},"Pragyat Thakur","+910160 281 0022","pragyat28rpgmc@gmail.com",{"name":92,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":97,"status":39,"city":98,"state":88,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Homi Bhabha Cancer Hospital, Sangrur","Sangrur","148001",{"type":58,"coordinates":101},[102,103],75.84488,30.24506,{"lat":103,"lon":102},[106,109],{"name":107,"role":32,"phone":48,"phoneExt":25,"email":108},"Jayashree Deshmkh","drjanvi299@gmail.com",{"name":110,"role":51,"phone":25,"phoneExt":25,"email":25},"Jayashree Deshmukh",{"facility":112,"status":39,"city":113,"state":114,"zip":115,"country":43,"countryCode":44,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Mahamana Pandit Madan Mohan Malviya Cancer Centre","Varanasi","Uttar Pradesh","221005",{"type":58,"coordinates":117},[118,119],83.01041,25.31668,{"lat":119,"lon":118},[122,126],{"name":123,"role":32,"phone":124,"phoneExt":25,"email":125},"Lincoln Pujari","+910542 691 7700","lincoln.puraji@gmail.com",{"name":123,"role":51,"phone":25,"phoneExt":25,"email":25},{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Dr. Tabassum Wadasadawala","Professor and Radiation oncologist","100587296","phase-3-postoperative-radiotherapy-in-breast-cancer--concurrent-or-sequential-with-chemotherapy-100587296",false,"NCT06926543","Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy","Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)","CONCERT","Inclusion Criteria:\n\n1. Pathologically confirmed invasive breast cancer\n2. Stage IIB-III invasive breast cancer (AJCC 8th edition)\n3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy\n4. Patients fit to receive adjuvant chemotherapy and radiotherapy\n5. Age \\> 18 years\n\nExclusion Criteria:\n\n1. Hypersensitivity to taxanes\n2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)\n3. Unable or unwilling for regular follow up\n4. Bilateral tumour needed RT to both sides\n5. Patients planned for RT to oligometastatic sites\n6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and\u002For lungs (Exceeding the protocol specific mandatory dose constraints).\n7. Pregnant patient","ALL","18 Years",{"count":142,"type":143},858,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:\n\n1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?\n2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?\n3. What are each treatment approach's financial costs?\n\nResearchers will compare the following to groups:\n\nArm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation.\n\nand Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy.\n\nParticipants are going to:\n\n1. Get the usual chemotherapy (taxanes and\u002For anthracyclines).\n2. Receive radiation therapy for three to four weeks.\n3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.",[149,150,151],"Invasive Breast Cancer","Stage III Breast Cancer","Stage IIB Breast Cancer",[153,22,154,155,156],"Invasive breast cancer","Sequential","Concurrent","adjuvant therapy","2025-04-07",{"date":159,"type":160},"2025-04-13","ACTUAL",{"date":162,"type":160},"2024-05-14",{"date":164,"type":143},"2031-05",{"name":129,"class":6},5]