[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450331":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":120,"collaborators":123,"id":128,"slug":40,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":40,"studyType":142,"phases":143,"briefSummary":146,"conditions":147,"keywords":40,"overallStatus":150,"whyStopped":40,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Surgery +\u002F- Neck Dissection","EXPERIMENTAL","Patients would undergo appropriate surgery via open, endoscopic, TLM, TORS or a combination. The primary and the neck would be addressed. For N0 neck, clearance of levels II-IV will be required, with levels I and\u002For V electively dissected at the discretion of the operating surgeon and based on extension of nodal disease. For N+ neck and tumors approaching to within 1cm of the midline, we recommend a contralateral neck dissection be performed as well of levels II-IV but to be done as per operating team's discretion. For lateralized lesions of the BOT and tonsil, ipsilateral neck dissection will be performed. A minimum of 18 lymph nodes per dissected side of the neck is required and will be subject to quality assurance review",[13],"Procedure: Surgery with or without Neck Dissection",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2 - Chemoradiation","Patients will receive IMRT with normal tissue sparing techniques (70Gy\u002F35# or 66Gy\u002F 30#) along with concurrent weekly cisplatin. Weekly cisplatin will be administered during IMRT at a dose of 40 mg\u002Fm2 IV on days 1, 8, 15, 22, 29, 36, and 43 for a total of up to 7 weekly doses, administered during the course of IMRT.\n\nFor patients with T1-2 lateralized tonsil tumors with \\\u003C1 cm invasion into the soft palate, no invasion of BOT, and N1 neck involvement, unilateral neck will be irradiated. The contralateral neck will be addressed for some BOT tumors\\\u003C1cm or at the midline and may be considered in patients with N2 and N3status. For patients with residual neck disease after CCRT, a formal neck dissection will be performed. For patients with residual primary disease after CCRT, surgery for the primary will be performed if feasible.",[18,19],"Radiation: Radiation","Drug: Cisplatin based chemotherpay",[21,28,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Surgery with or without Neck Dissection","An appropriate surgery as open, endoscopic, TLM, TORS or a combination with or without neck dissection e.g. levels dissected, sparing or sacrifice of the SCM, accessory nerve, etc as per patient disease and status will be performed",[9],[27],"appropriate surgery as open, endoscopic, TLM, TORS or a combination with or without neck dissection",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"RADIATION","Radiation","Patients will receive IMRT with normal tissue sparing techniques (70Gy\u002F35# or 66Gy\u002F 30#) along with concurrent weekly cisplatin. Weekly cisplatin will be administered during IMRT at a dose of 40 mg\u002Fm2 IV on days 1, 8, 15, 22, 29, 36, and 43 for a total of upto 7 weekly doses, administered during the course of IMRT.",[15],[34],"Radiotherapy with IMRT with normal tissue sparing techniques",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Cisplatin based chemotherpay","Cisplatin (dose-40 mg\u002Fm2weekly,upto6-7cycles) cycle 1 will be administered within first 2 # of radiation. The rest of the cycles will be given weekly.",[15],null,[42],{"name":43,"affiliation":44,"role":45},"Deepa Nair, MS(ENT),DNB","Tata Memorial Hospital, Mumbai, India","PRINCIPAL_INVESTIGATOR",[47,52],{"name":43,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","9820901792","7282","drdeepanair78@gmail.com",{"name":53,"role":48,"phone":54,"phoneExt":40,"email":55},"Sarbani Ghosh-Laskar","9820834386","sarbanilaskar@gmail.com",[57],{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Tata Memorial Hospital","Mumbai","Maharashtra","400012","India","IN",{"type":65,"coordinates":66},"Point",[67,68],72.88261,19.07283,{"lat":68,"lon":67},[71,73,75,78,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118],{"name":72,"role":48,"phone":40,"phoneExt":40,"email":40},"Deepa Nair, MS, DNB",{"name":74,"role":45,"phone":40,"phoneExt":40,"email":40},"Deepa Nair, MS,DNB",{"name":76,"role":77,"phone":40,"phoneExt":40,"email":40},"Pankaj Chaturvedi","SUB_INVESTIGATOR",{"name":79,"role":77,"phone":40,"phoneExt":40,"email":40},"Devendra Chaukar",{"name":81,"role":77,"phone":40,"phoneExt":40,"email":40},"Prathamesh Pai",{"name":83,"role":77,"phone":40,"phoneExt":40,"email":40},"Gouri Pantvaidya",{"name":85,"role":77,"phone":40,"phoneExt":40,"email":40},"Sudhir Nair",{"name":87,"role":77,"phone":40,"phoneExt":40,"email":40},"Anuja Deshmukh",{"name":89,"role":77,"phone":40,"phoneExt":40,"email":40},"Shivakumar Thiagarajan",{"name":91,"role":77,"phone":40,"phoneExt":40,"email":40},"Richa Mahajan",{"name":93,"role":77,"phone":40,"phoneExt":40,"email":40},"Poonam Joshi",{"name":95,"role":77,"phone":40,"phoneExt":40,"email":40},"Vidisha Tuljapurkar",{"name":97,"role":77,"phone":40,"phoneExt":40,"email":40},"Ashwini Budrukkar",{"name":99,"role":77,"phone":40,"phoneExt":40,"email":40},"Naveen Mummudi",{"name":101,"role":77,"phone":40,"phoneExt":40,"email":40},"Monali Swain",{"name":103,"role":77,"phone":40,"phoneExt":40,"email":40},"Kumar Prabhash",{"name":105,"role":77,"phone":40,"phoneExt":40,"email":40},"Amit Joshi",{"name":107,"role":77,"phone":40,"phoneExt":40,"email":40},"Vijay Patil",{"name":109,"role":77,"phone":40,"phoneExt":40,"email":40},"Nandini Menon",{"name":111,"role":77,"phone":40,"phoneExt":40,"email":40},"Asawari Patil",{"name":113,"role":77,"phone":40,"phoneExt":40,"email":40},"Munita Bal",{"name":115,"role":77,"phone":40,"phoneExt":40,"email":40},"Neha Mittal",{"name":117,"role":77,"phone":40,"phoneExt":40,"email":40},"Arun Balaji",{"name":119,"role":77,"phone":40,"phoneExt":40,"email":40},"Sadhana Kannan",{"type":45,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Dr.Deepa Nair","Professor, Surgical Oncology",[124,126],{"name":125,"class":6},"All India Institute of Medical Sciences",{"name":127,"class":6},"Amrita Institute of Medical Sciences & Research Center","100450331",false,"NCT05144100","Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II\u002FIII Integrated Design Randomized Control Trial","Primary Surgery Vs Primary Chemoradiation for Oropharyngeal Cancer (Scope Trial) - A Phase II\u002FIII Integrated Design Randomized Control Trial","SCOPE","Inclusion Criteria:\n\n1. Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and\u002For lateralized tongue-base\n2. ECOG Performance Status ≤2\n3. Age ≥18 to 70 years\n4. Anesthetic fitness obtained for surgery under general anesthesia\n5. Resectable primary tumor with an anticipation of achieving resection free margins either by minimally invasive\u002Fopen techniques\n6. Clinical stage III or IV, i.e. T1-T2 or T3-T4 with N0-N3. Nodal disease withextranodal extension on clinical examination\u002Fimaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon\n7. HPV negative status determined by p16 status.\n8. No distant metastases below the clavicles, based upon the following minimum diagnostic workup:\n\n   1. History\u002Fphysical examination by the physician.\n   2. Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT\u002FPET-CT for distant metastatic workup)\n9. Patients with no contraindications to Cisplatin chemotherapy and radiotherapy\n10. Adequate organ function\n\n    1. Hematological- Hb\\> 10 g\u002FL, ANC ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL.\n    2. Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST\u002FALT\u002F ALP ≤ 2.5 x ULN, S. albumin ≥ 30 g\u002FL.\n    3. Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \\> 50 mL\u002Fmin.\n11. Women of child bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial\n12. Patients who can be followed up and must be able to provide informed consent prior to study entry\n\nExclusion Criteria:\n\n1. Prior head and neck malignancy\n2. Prior invasive malignancy, unless disease free for a minimum of 3 years\n3. Prior chemotherapy for a different cancer administered within 3 years prior to registration\n4. Patients who have received any neoadjuvant\u002F induction chemotherapy\n5. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields\n6. Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base\n7. Large soft palate involvement \\>1 cm\n8. Deep extension into larynx, pre-epiglottic space and deep invasion into extrinsic muscles of tongue\n9. Calculated GFR \\\u003C 50 cc\u002Fmin\n10. Patients who have uncontrolled cardiac comorbidity\n\n    1. QTc prolongation (a value of \\>450 milliseconds)\n    2. Ejection fraction below 50%\n    3. Presence of regional wall akinesia\n11. Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year\n12. Presence of severe malnutrition as defined by body mass index of below 16kg per m2 or presence of weight loss of greater than 20% in last 6 months\n13. Severe active co-morbidities such as severe cardiac failure, severe pulmonary compromise, type 1or 2 diabetes mellitus (Hb1ac of \\> 8 mg\u002Fdl) severe and active infections or life expectancy less than 6 months\n14. Prior allergic reaction to cisplatin\n15. Radiographic evidence of retropharyngeal and\u002For level VI metastasis\n16. Patients on other investigational drugs within last 30 days",true,"ALL","18 Years","70 Years",{"count":140,"type":141},498,"ESTIMATED","INTERVENTIONAL",[144,145],"PHASE2","PHASE3","The oropharyngeal areas mainly comprises of the tonsil, base tongue (BOT), soft palate and the posterior pharyngeal wall. Traditionally, surgical resection of oropharyngeal cancers (OPC) was a standard procedure, often performed through mutilating incisions with mandibulotomies, rendering significant post-operative functional deficits. Over the past 2 decades, there has been a major shift in treatment strategy with a majority of these cancers now being treated by primary concurrent chemoradiation (CCRT) with a trend towards organ and function preservation.",[148,149],"Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","NOT_YET_RECRUITING","2021-11-22",{"date":153,"type":154},"2021-12-03","ACTUAL",{"date":156,"type":141},"2021-12-01",{"date":158,"type":141},"2031-06-30",{"name":5,"class":6},1]