[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572788":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":127,"collaborators":130,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":26,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Jodhpur","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surg Arm","ACTIVE_COMPARATOR","Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines",[13],"Combination Product: Surgery and Adjuvant Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"ICT Arm","EXPERIMENTAL","2# of Chemotherapy before the Stadrard Surery: Either TPF or TPX Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines",[19],"Combination Product: TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment","TPF:\n\nIINJ DOCETAXEL 75mg\u002FM2 in 500 ML NORMAL SALINE(PVC free container\u002Fglass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG\u002FM 2 IN 500 ML NS IV OVER 1 HOUR ON DAY1 ONLY INJ. 5FU 750 MG\u002FM2 IV THROUGH INFUSION PUMP OVER 24 HOURS D 1-4\n\nOr\n\nTPX Regimen INJ DOCETAXEL 75mg\u002FM2 in 500 ML NORMAL SALINE(PVC free container\u002Fglass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG\u002FM 2 IN 500 ML NS IV OVER 1 HOUR ON D1 ONLY TAB. CAPECITABINE 850-1000MG\u002FM2 TWICE A DAY 30 MINUTES AFTER MEALS FOR 14 DAYS IN A THREE WEEKLY CYCLE\n\nSurgery and Adjuvant Treatment Patients with PR\u002FCR or SD will go for surgical resection. Patients having PD but still localized and resectable will be offered surgical resection, other would undergo radical CTRT or Palliative Treatment.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Surgery and Adjuvant Treatment","Wide Local Excision (WLE) with Comprehensive neck dissection and Adjuvant Treatment as per current standard Guidelines.",[9],[32],{"name":33,"affiliation":34,"role":35},"Dharma R Poonia, MS DNB","AIIMS Jodhpur","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","9958654196","pooniadr@aiimsjodhpur.edu.in",[42,59,72,83,94,105,116],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"All India Institute of Medical Sciences, Bhubaneshwar","NOT_YET_RECRUITING","Bhubaneswar","Odisha","751019","India","IN",{"type":51,"coordinates":52},"Point",[53,54],85.83385,20.27241,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":26,"phoneExt":26,"email":26},"Dillip Mudully",{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"RECRUITING","Jodhpur","Rajasthan","342005",{"type":51,"coordinates":65},[66,67],73.00594,26.26841,{"lat":67,"lon":66},[70,71],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":73,"status":44,"city":74,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"All India Institute of Medical Sciences, Bathinda","Bathinda",{"type":51,"coordinates":76},[77,78],74.93893,30.20747,{"lat":78,"lon":77},[81],{"name":82,"role":38,"phone":26,"phoneExt":26,"email":26},"Rohit Mahajan",{"facility":84,"status":44,"city":85,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Shri Mahant Indresh Hospital, Dehradun","Dehradun",{"type":51,"coordinates":87},[88,89],78.03392,30.32443,{"lat":89,"lon":88},[92],{"name":93,"role":38,"phone":26,"phoneExt":26,"email":26},"Pankaj K Garg",{"facility":95,"status":44,"city":96,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"King George's Medical University","Lucknow",{"type":51,"coordinates":98},[99,100],80.92313,26.83928,{"lat":100,"lon":99},[103],{"name":104,"role":38,"phone":26,"phoneExt":26,"email":26},"Vijay Kumar",{"facility":106,"status":44,"city":107,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"All India Institute of Medical Sciences, Rishikesh","Rishikesh",{"type":51,"coordinates":109},[110,111],78.29255,30.10778,{"lat":111,"lon":110},[114],{"name":115,"role":38,"phone":26,"phoneExt":26,"email":26},"Amit Sehrawat",{"facility":117,"status":44,"city":118,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Geetanjali Medical College, Udaipur","Udaipur",{"type":51,"coordinates":120},[121,122],73.71346,24.58584,{"lat":122,"lon":121},[125],{"name":126,"role":38,"phone":26,"phoneExt":26,"email":26},"Ashish Jhakhetiya",{"type":35,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dharma Ram Poonia","Principal Investigator & Associate Professor Surgical Oncology",[131,132,135,136,137,140],{"name":106,"class":6},{"name":133,"class":134},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",{"name":73,"class":6},{"name":95,"class":134},{"name":138,"class":139},"Shri Mahant Indiresh Hospital, Dehradun","UNKNOWN",{"name":117,"class":139},"100572788","phase-3-upfront-surgery-vs-induction-chemotherapy-followed-by-surgery-in-oral-cancers-100572788",false,"NCT06737822","Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:","Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cavity Squamous Cell Cancers With Advanced Nodal Disease (SurVIC Trial): A Phase 3 Multicentric Randomized Controlled Trial","SurVIC","Inclusion Criteria:\n\n* Newly diagnosed, treatment naïve, biopsy or cytology proven OSCC\n* Clinical Stage cT1-4a, cN2-N3\\*\\*, M0- as per UICC 2018\n* No evidence of distant metastases on chest x-ray and\u002For CT Thorax\n* ECOG PS 0-2\n* No contraindication to Cisplatin or radiotherapy\\*\\*\\*\n* Patients eligible for definitive curative intent treatment after discussion in multidisciplinary tumour board\n* Adequate organ function at time of participation, defined as Haematological: Haemoglobin \\> 9gm\u002Fdl, ANC ≥ 1500\u002Fcmm3, Platelet ≥100000\u002Fcmm3 Liver Function test: Bilirubin ≤2 x upper limit normal (ULN), AST\u002FALT\u002F ALP ≤ 2.5 x ULN Renal Function test: Creatinine ≤ 1.5 ULN, Creatinine Clearance ≥60 ml\u002Fmin.\n\nExclusion Criteria:\n\n* Pregnant\n* History of moderate to severe hearing loss.\n* History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ.\n* Documented Weight loss of more than 15% in the last 6 months.\n* Patients with known HIV, hepatitis B or C infection.","ALL","18 Years","75 Years",{"count":153,"type":154},346,"ESTIMATED","INTERVENTIONAL",[157],"PHASE3","A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Attempted trials of neoadjuvant chemotherapy failed to show oncological advantage despite an excellent response rate, in part due to poor patient selection. Patients with a biologically aggressive disease are more likely to benefit, hence we intend to find out the oncological advantage of adding induction chemotherapy to oral squamous cell cancer with advanced nodal disease (N2-N3).\n\nEarlier studies suffered from their heterogeneous patient population- all head and neck subsites together and included a spectrum ranging from early- stage operable cases to inoperable cancer. Due to such patient selection, the intended results were never met. The current study is intended to study the role of chemotherapy in curable patients who are most likely to benefit (biologically aggressive and advanced stage of presentation).\n\nObjective\n\nPrimary:\n\nTo study the 2 year disease free survival by adding induction chemotherapy before surgery in patients of oral cancer with advanced nodal disease as compared to upfront surgery.\n\nSecondary:\n\nTo assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications and Quality of life.\n\nTo study the overall survival at 2 years. Oral cancer tissue biobanking for future translational research.\n\nStudy population Operable Oral cavity Squamous cell carcinoma with advanced nodal disease (N2-N3) Study Design Open label, Multi centric, randomized controlled trial with allocation ratio of 1:1\n\nSample Size The primary end point is disease-free survival. In order to have 80% power to detect a hazard ratio of 0.67, using a two-sided significance level, a total of 184 events are needed. Assuming an accrual rate of 15 patients a month, 300 patients need to be recruited. The analysis of DFS will take place 32 months after the start of the trial. The follow-up of patients will continue for 5 years. The analysis of OS will be conducted when 184 deaths are observed. taking 10% of withdrawal of consent, a total of 346 patients need to be included.\n\nInclusion Criteria Biopsy proven, operable oral Squamous cell carcinoma cT1-T4; cN2-N3, with adequate organ function, Age- 18-75 years, ECOG-PS:0-2 Treatment Arms\n\nStandard Arm (SURG arm):\n\nSurgery (Wide local Excision\u002Fcomposite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy\n\nExperimental Arm (ICT):\n\n2# TPF or TPX based induction chemotherapy followed by Surgery (Wide local Excision\u002Fcomposite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy\n\nStudy endpoints Primary- Disease free survival Secondary- Overall survival\u002F Quality of life\u002F Toxicity of treatment\u002F Treatment tolerance",[160,161],"Oral Cancer","Head and Neck Neoplasms","2025-03-02",{"date":164,"type":165},"2025-03-04","ACTUAL",{"date":167,"type":165},"2024-12-20",{"date":169,"type":154},"2029-10",{"name":5,"class":6},7]