[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648631":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":70,"collaborators":26,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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 involving cervical lymph node levels I, II, and III.","ACTIVE_COMPARATOR","The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa and III. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious\u002Fsuspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.",[13],"Procedure: Intervention : Selective Neck Dissection (Levels I-III)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2- Selective neck dissection level I, II, III and IV","EXPERIMENTAL","The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa, III and IV. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious\u002Fsuspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.",[19],"Procedure: Selective Neck Dissection (Levels I-IV)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Selective Neck Dissection (Levels I-IV)","Selective Neck Dissection (Levels I-IV)- Selective neck dissection (Levels I-IV) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, III, and IV during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Intervention : Selective Neck Dissection (Levels I-III)","Selective neck dissection (Levels I-III) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, and III during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.",[9],[32],{"name":33,"affiliation":34,"role":35},"Maroti B Wadewale, MDS, FHNO","Kolhapur Cancer Centre","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+918483851334","dr.marotiwadewale59@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Parag J Watve, MS, FHNS","+919823109918","paragwatve@kolhapurcancercentre.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Kolhapur Cancer Centre- Cancer Centers of America","RECRUITING","Kolhāpur","Maharashtra","416234","India","IN",{"type":55,"coordinates":56},"Point",[57,58],74.23167,16.69563,{"lat":58,"lon":57},[61,63,67,68],{"name":62,"role":38,"phone":39,"phoneExt":26,"email":44},"Parag Watve, MS, FHNS",{"name":64,"role":38,"phone":65,"phoneExt":26,"email":66},"Yogesh Anap, MD","+919867155930","yogesh.anap1@gmail.com",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":42,"role":69,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Maroti Wadewale","Consultant","100648631","study-comparing-different-neck-treatment-approaches-in-patients-with-oral-cancer-without-visible-neck-spread-100648631",false,"NCT07726199","Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread","ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial","ExtentN0","Inclusion Criteria:\n\n* Patients aged over 21 years will be included.\n* Histologically proven squamous cell carcinoma of oral cavity will be included\n* Clinical stage T1-T4, N0, M0\n* cN0 neck on clinical examination and imaging (CT\u002FMRI)\n* American Society of Anesthesiologists (ASA) Physical Status I or II\n* Understands the protocol\n* and can give informed consent.\n\nExclusion Criteria:\n\n* Recurrent cases\n* FNAC proven Positive cervical nodes\n* Patients with history of head and neck radiation therapy treatment\n* Previous neck surgery or radiotherapy\n* Previous history of any cancer","ALL","21 Years","75 Years",{"count":85,"type":86},267,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn whether selective neck dissection involving lymph node levels I-III is as effective as selective neck dissection involving levels I-IV in treating adults with clinically node-negative (cN0) oral squamous cell carcinoma undergoing curative surgery. It will also evaluate whether extending the neck dissection to level IV affects cancer control, surgical complications, shoulder function, and quality of life. The main questions it aims to answer are:\n\n* Does selective neck dissection of levels I-III provide regional recurrence-free survival comparable to selective neck dissection of levels I-IV?\n* Does extending the neck dissection to level IV improve overall survival, disease-free survival, or reduce regional recurrence?\n* Does selective neck dissection of levels I-III result in less postoperative morbidity, better shoulder function, and improved quality of life compared with selective neck dissection of levels I-IV?\n\nResearchers will compare patients undergoing selective neck dissection of levels I-III with those undergoing selective neck dissection of levels I-IV to determine whether routine removal of level IV lymph nodes provides additional oncological benefit while maintaining acceptable functional outcomes.\n\nParticipants will:\n\n* Undergo surgery for oral squamous cell carcinoma with random assignment to selective neck dissection of either levels I-III or levels I-IV.\n* Receive standard postoperative treatment, including radiotherapy or chemoradiotherapy when indicated according to the final pathology report.\n* Attend scheduled follow-up visits for clinical examinations and surveillance for cancer recurrence.\n* Undergo assessments of shoulder function, sensory function, postoperative complications, and quality of life using validated questionnaires at predefined follow-up intervals.",[92],"Oral Squamous Cell Carcinoma (OSCC)",[94,95,96,97,98,99,100,101],"Oral Squamous Cell Carcinoma","Oral Cancer","cN0","Selective Neck Dissection","Occult Nodal Metastasis","Regional Recurrence","Head and Neck Cancer","Randomized Controlled Trial","2026-08-01",{"date":104,"type":105},"2026-08-04","ACTUAL",{"date":107,"type":105},"2026-04-22",{"date":109,"type":86},"2030-09-01",{"name":5,"class":6},1]