[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100364002":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":37,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic PEG","EXPERIMENTAL","Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal \u002F kg adapted and 1.2 to 1.5 g \u002F prot.\u002F kg.BW) with an increase as needed during the treatment.",[13,14,15],"Device: Percutaneous Endoscopic Gastrotomy tube placement","Drug: Cisplatin injection","Radiation: Radiotherapy",{"label":17,"type":10,"description":18,"interventionNames":19},"Reactive PEG","Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2\u002F3 of estimated energy requirements (based on 30-35 kcal \u002F adapted kg .BW and 1.2 - 1.5 g\u002Fprot.\u002Fadapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).",[13,14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Percutaneous Endoscopic Gastrotomy tube placement","placement of the PEG tube depends on arm",[9,17],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Cisplatin injection","Two therapeutic regimen allowed:\n\n* Days 1 and 22 : cisplatin 100mg\u002Fm2 IV\n* Days 1,8,15,22,29,36: weekly cisplatin 40 mg\u002Fm2 IV",[9,17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":26},"RADIATION","Radiotherapy","Simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV.",[9,17],[38,56],{"facility":39,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"CHU Saint Pierre","NOT_YET_RECRUITING","Brussels","1000","Belgium","BE",{"type":46,"coordinates":47},"Point",[48,49],4.34878,50.85045,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":26,"phoneExt":26,"email":55},"Petra Boegner","CONTACT","petra_boegner@stpierre-bru.be",{"facility":57,"status":58,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Institut Jules Bordet","RECRUITING",{"type":46,"coordinates":60},[48,49],{"lat":49,"lon":48},[63],{"name":64,"role":54,"phone":65,"phoneExt":26,"email":66},"Tatiana Dragan","0032 241 3727","tatiana.dragan@bordet.be",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100364002","phase-3-assessment-of-swallowing-function-and-quality-of-life-in-oropharyngeal-cancer-patients-treated-by-chemo-radiotherapy-100364002",false,"NCT04019548","Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy","Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy","SwallPEG","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. ECOG performance status ≤ 2\n3. Female and Male\n4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx\n5. Candidate for curative intent radiotherapy and systemic treatment\n6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)\n7. Diagnosis biopsy results\n8. HPV\u002Fp 16 testing results\n9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.\n10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.\n11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.\n12. Adequate bone marrow function as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1500\u002FµL or 1.5x109\u002FL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Platelets ≥100000\u002FµL or 100x109\u002FL\n13. Adequate liver function as defined below:\n\n    * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \\\u003C 3 x UNL is allowed\n    * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n14. Adequate renal function as defined below:\n\n    * Creatinine ≤ 1.5 x UNL and creatinine clearance \\> 60 mL\u002Fmin\n15. Peripheral neuropathy ≤ grade 1\n16. Hear impaired ≤ grade 1\n17. Completion of all necessary screening procedures within 15 days prior to randomisation.\n18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening\n\nExclusion Criteria:\n\n1. Severe malnutrition\n2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\\_v.5)\n3. Distant metastasis\n4. Serious coagulation disorders (INR\\>1.5, PTT\\>50s, platelets \\\u003C50000\u002Fmm3)\n5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal\u002Fsquamous cell carcinoma of the skin;\n7. Pregnant and\u002For lactating women.\n8. Known hypersensitivity to the study drug (cisplatin) or excipients.","ALL","18 Years",{"count":80,"type":81},110,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.\n\nStudy is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.\n\nAll subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).",[87],"Oropharyngeal Cancer","2023-05-09",{"date":90,"type":91},"2023-05-10","ACTUAL",{"date":93,"type":91},"2019-12-16",{"date":95,"type":81},"2030-05-01",{"name":5,"class":6},2]