[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648068":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":67,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Kolhapur Cancer Centre - Cancer Centers of America","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1- Selective neck dissection level I to level IV","EXPERIMENTAL","Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.",[13],"Procedure: Selective Neck Dissection (Levels I-IV)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2- Modified Neck Dissection (Levels I-V)","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.",[19],"Procedure: Modified Neck Dissection (Levels I-V)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Selective Neck Dissection (Levels I-IV)","Selective neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Modified Neck Dissection (Levels I-V)","Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Maroti B Wadewale, MDS, FHNO","CONTACT","+918483851334","dr.marotiwadewale59@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Parag J Watve, MS, FHNS","+919823109918","paragwatve@kolhapurcancercentre.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kolhapur Cancer Centre","RECRUITING","Kolhāpur","Maharashtra","416004","India","IN",{"type":51,"coordinates":52},"Point",[53,54],74.23167,16.69563,{"lat":54,"lon":53},[57,58,62,64],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":59,"role":34,"phone":60,"phoneExt":26,"email":61},"Yogesh Anap, MD","+919867155930","yogesh.anap1@gmail.com",{"name":33,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Parag Watve, MS, FHNS","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Maroti Wadewale","Consultant, Head and neck surgical oncology","100648068","study-comparing-limited-and-extensive-neck-surgery-in-oral-cancer-patients-with-neck-spread-100648068",false,"NCT07717307","Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread","Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial","ExtentN1","Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of oral cavity will be included\n* Clinical stage T1-T4, N1, M0\n* cN1 neck on clinical examination and imaging (CT\u002FMRI)\n* Single node which is FNAC proven without any other significant nodes.\n* Patients with ASA grade II and I.\n* Understands the protocol and able to give informed consent.\n\nExclusion Criteria:\n\n* Recurrent cases\n* Multiple significant nodes\n* Nodes clinical\u002Fradiological with ENE\n* Single metastatic node at level III\u002FIV\u002FV\n* Single metastatic node with other suspicious nodes\n* Patients with a history of head and neck radiation therapy treatment\n* Previous history of any malignancy","ALL","21 Years","75 Years",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"NA","Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking.\n\nThe ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm.\n\nThe primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities.\n\nThis trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.",[89],"Oral Cavity Squamous Cell Carcinoma",[89,91,92,93,94,95],"Oral Cancer","Head and Neck Cancer","Neck Dissection","Modified Neck Dissection","Cervical Lymph Node Metastasis","2026-08-01",{"date":98,"type":99},"2026-08-04","ACTUAL",{"date":96,"type":99},{"date":102,"type":83},"2031-04-23",{"name":5,"class":6},1]