[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633577":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":65,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":27,"overallStatus":46,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","ACTIVE_COMPARATOR","Post operative radiotherapy to primary tumor bed and regional lymphatics",[13,14],"Radiation: IMRT - adjuvant concurrent CRT\u002F RT","Drug: Cisplatin",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B","EXPERIMENTAL","Post operative radiotherapy to primary tumor bed but omission of PORT to regional lymphatics",[20,14],"Radiation: ommission of IMRT - adjuvant concurrent CRT\u002F RT for regional lymphatics",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","IMRT - adjuvant concurrent CRT\u002F RT","IMRT - adjuvant concurrent CRT\u002F RT as 66Gy\u002F33fr or 60Gy\u002F30fr or 50Gy\u002F20fr to primary and regional lymphatics",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"ommission of IMRT - adjuvant concurrent CRT\u002F RT for regional lymphatics","IMRT- adjuvant concurrent CRT\u002F RT as 66Gy\u002F33fr or 60Gy\u002F30fr or 50Gy\u002F20fr \u002F Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only\n\n\\- elimination of regional lymphatics",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DRUG","Cisplatin","Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg\u002Fm2 weekly to a cumulative dose of at least 200 mg\u002Fm2 in case of margin positive disease.",[9,16],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Aman Sharma, MD","CONTACT","+91117018529339","amans757@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Nci, Aiims","RECRUITING","Jhajjar","Haryana","124105","India","IN",{"type":53,"coordinates":54},"Point",[55,56],76.6565,28.6063,{"lat":56,"lon":55},[59],{"name":39,"role":40,"phone":60,"phoneExt":27,"email":42},"+917018529339",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Aman Sharma","Associate Professor, Principal Investigator, Radiation Oncology",[66,69,71],{"name":67,"class":68},"All India Institute of Medical Sciences, Rishikesh","OTHER_GOV",{"name":70,"class":68},"All India Institute of Medical Sciences, Raipur",{"name":72,"class":68},"Jawaharlal Institute of Postgraduate Medical Education & Research","100633577","phase-2-a-trial-evaluating-omission-of-radiotherapy-to-regional-lymphatics-100633577",false,"NCT07528495","A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's","The Eliminate Trial: A Phase II\u002FIII Randomised Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's in pN0\u002FN1 Neck for Oral Cavity Carcinomas","Eliminate","Inclusion Criteria:\n\n1. Aged 18 or above and less than 70 years\n2. Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral\u002Fbilateral neck dissection.\n3. Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4\n4. At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)\n5. Pathological N0\u002F N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity\n6. Brandwein-Gensler (BG) histological risk assessment in all patients\n7. Karnofsky performance score greater or equal 70\n8. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.\n9. Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics)\n10. Written informed consent for treatment.\n11. Available to attend long term follow- up\n\nExclusion Criteria:\n\n1. Non squamous histology\n2. Presences of distant metastases\n3. pT1-2 disease and no high risk features\n4. Pathologically N2\u002FN3 disease.\n5. Patients that require re-irradiation for recurrent disease\n6. Inadequate neck dissection (less than 12 nodes examined)\n7. Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done\n8. Initiation of PORT after 8 weeks of radical surgery.\n9. Previous radiotherapy to the head and neck region\n10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).\n11. Age \\\u003C 18 years or \\> 70 years\n12. Brandwein-Gensler (BG) histological risk not done",true,"ALL","18 Years","70 Years",{"count":86,"type":87},396,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE2","PHASE3","The present study is a phase II\u002FIII prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.",[94],"Head and Neck Cancer","2026-04-30",{"date":97,"type":98},"2026-05-06","ACTUAL",{"date":100,"type":98},"2024-04-03",{"date":102,"type":87},"2028-04-03",{"name":5,"class":6},1]