[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498763":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":81,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":114,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Tata Memorial Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sentinel node biopsy","ACTIVE_COMPARATOR",null,[13],"Procedure: Sentinel Node Biopsy",{"label":15,"type":16,"description":11,"interventionNames":17},"Limited elective neck dissection","EXPERIMENTAL",[18],"Procedure: Limited Elective Neck Dissection",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Sentinel Node Biopsy","The Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Limited Elective Neck Dissection","Patients who are allocated to the limited END arm will undergo dissection of level I, IIa and III\u002FIV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb.",[15],[30],{"name":31,"affiliation":5,"role":32},"Richa Vaish, MS, M.Ch","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","02224177000","7238","drvaishricha@gmail.com",[40,56,67],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Mumbai","Maharashtra","400012","India","IN",{"type":48,"coordinates":49},"Point",[50,51],72.88261,19.07283,{"lat":51,"lon":50},[54],{"name":31,"role":35,"phone":55,"phoneExt":37,"email":38},"022-24177000",{"facility":57,"status":58,"city":59,"state":43,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"ACTREC","NOT_YET_RECRUITING","Navi Mumbai",{"type":48,"coordinates":61},[62,63],73.01582,19.03681,{"lat":63,"lon":62},[66],{"name":31,"role":35,"phone":55,"phoneExt":11,"email":38},{"facility":68,"status":58,"city":69,"state":70,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Mpmmcc & Hbch","Varanasi","Uttar Pradesh",{"type":48,"coordinates":72},[73,74],83.01041,25.31668,{"lat":74,"lon":73},[77],{"name":78,"role":35,"phone":79,"phoneExt":11,"email":80},"Aseem Mishra, MS, M.Ch","0542-6917700","draseemmishra@gmail.com",{"type":32,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Richa Vaish","Professor and Surgeon",[85],{"name":86,"class":87},"Tata Memorial Centre","OTHER","100498763","sentinel-node-biopsy-versus-limited-elective-neck-dissection-in-early-cancers-of-oral-cavity-node-negative-100498763",false,"NCT05774483","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial","SECOND N0","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa\n3. T1 and T2 lesions as per AJCC TNM 8 edition\n4. Clinicoradiologically node negative\n5. Amenable to per oral excision\n6. Treatment naïve\n7. No other site of malignancy\n\nExclusion Criteria:\n\n1. Previous surgery in the head and neck region,\n2. Upper alveolar or palatal lesions\n3. Large heterogeneous leukoplakia or other premalignant lesions\n4. Previous malignancy in the head and neck region\n5. Patients requiring the free flap reconstruction","ALL","18 Years","80 Years",{"count":100,"type":101},508,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.\n\nThe main questions it aims to answer are:\n\n* Survival outcomes\n* Morbidity outcomes\n* Cost-effectiveness\n\nParticipants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.",[107,108,109,110,111,112,113],"Mouth Neoplasms","Oral Cancers","Oral Squamous Cell Carcinoma (OSCC)","Oral Squamous Cell Carcinomas","Sentinel Lymph Node Biopsy","Sentinel Lymph Node Biopsy (SLNB)","Sentinel Lymph Node",[115,116,117,118,119,120,121],"mouth neoplasms","neck dissection","sentinel lymph node biopsy","survival","morbidity","oral cancers","oral squamous cell carcinoma","2025-07-14",{"date":124,"type":125},"2025-07-17","ACTUAL",{"date":127,"type":125},"2025-04-16",{"date":129,"type":101},"2034-04",{"name":5,"class":6},3]