[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522822":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":52,"centralContacts":57,"locations":63,"responsibleParty":85,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":30,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":47,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":47,"overallStatus":65,"whyStopped":47,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Rajiv Gandhi Cancer Institute & Research Center, India","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 3 - DE-HyART","EXPERIMENTAL","The radiation dose will be similar to 'arm 2'. In addition, the HSV identified on baseline FMISO scans will be contoured, and an isotropic margin of 5 mm will be given. This volume will be boosted in phase II to a total dose of 80 Gy. (Addition of 30 Gy in 3 Gy daily fraction added in phase II as a simultaneous integrated boost - SIB).",[13,14],"Radiation: DE-HyART","Drug: Cisplatin injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm 2 - Hypoxic Comparator Arm","ACTIVE_COMPARATOR","The prescribed radiotherapy dose will be 70 Gy in 2 Gy per fraction daily. The elective volume will be treated with 50 Gy in 2 Gy per fraction daily till the first 5 weeks. The entire treatment will be delivered in a phased mannered using sequential planning.",[20,14],"Radiation: Standard Arm",{"label":22,"type":23,"description":24,"interventionNames":25},"Arm 1 - Non-hypoxic arm","PLACEBO_COMPARATOR","The patients will be treated with a standard of care where the treatment will not be controlled, and these patients will act as external control representing clinical practice. However, these patients will be discussed in the head and neck multispeciality clinic and follow the institutional approach. They will be subjected to treatment similar to 'arm 2' but are allowed protocol deviation as per treating radiation oncology discretion.",[14,26],"Radiation: Standard fractionation (Radiation Oncology preference)",[28,37,42,48],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"RADIATION","DE-HyART","The HSV delineation will be done for patients in arm 3 using baseline FMISO. The HSV will be contoured and adjusted according to the second FMISO scan done between the 4th - the 5th week of radiation treatment. A planning CT will also be repeated at the time for adjusting the HSV to account for temporal changes. The Biological Target Volume thus generated after adequate margins will be prescribed 30 Gy in 10 fractions over and above the standard fractination.",[9],[34,35,36],"Dose escalated radiotherapy","Hypoxic sub volume","FMISO",{"type":29,"name":38,"description":18,"armGroupLabels":39,"otherNames":40},"Standard Arm",[16],[41],"Standard Sequential fractionation without dose escalation",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Cisplatin injection","Concurrent chemotherapy, weekly Inj Cisplatin 40mg\u002Fm2. This will be given if clinically indicated",[22,16,9],null,{"type":29,"name":49,"description":50,"armGroupLabels":51,"otherNames":47},"Standard fractionation (Radiation Oncology preference)","Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks",[22],[53],{"name":54,"affiliation":55,"role":56},"Munish Gairola, MD,DNB Radiation Oncology","Rajiv Gandhi Cancer Institute and Research Centre","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":47,"email":62},"Sarthak Tandon, DNB","CONTACT","+911147022009","tandon.sarthak@rgcirc.org",[64],{"facility":55,"status":65,"city":66,"state":47,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Delhi","110085","India","IN",{"type":71,"coordinates":72},"Point",[73,74],77.23149,28.65195,{"lat":74,"lon":73},[77,81,83],{"name":78,"role":60,"phone":79,"phoneExt":47,"email":80},"Sarthak Tandon, DNB Radiation Oncology","(+91)11-47022009","drsarthaktandon@yahoo.in",{"name":82,"role":56,"phone":47,"phoneExt":47,"email":47},"Munish Gairola, MD, DNB Radiation Oncology",{"name":78,"role":84,"phone":47,"phoneExt":47,"email":47},"SUB_INVESTIGATOR",{"type":56,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Munish Gairola","Dr",[89],{"name":90,"class":91},"Varian, a Siemens Healthineers Company","INDUSTRY","100522822","phase-2-dose-escalation-using-hypoxia-adjusted-radiotherapy-100522822",false,"NCT06087614","Dose Escalation Using Hypoxia-adjusted Radiotherapy","A Phase II Randomised Controlled Study Assessing the Role of Dose Escalation Using [18F] FMISO PET CT in Head and Neck Cancer: The DE-HyART (Dose Escalation Using Hypoxia-adjusted Radiotherapy) Protocol","Inclusion Criteria:\n\n* Age: 18 - 70 years\n* Willingness to sign informed consent (written\u002Fvideo documentation)\n* Performance status: ECOG 0 - 2\n* Histology proved - squamous cell carcinoma\n* Any grade, gender\n* Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx\n* Sufficient bone marrow reserve within the last 14 days.\n\n  * Hb: \\> 10g\u002Fdl (corrected)\n  * TLC: \\> 4,000 per cumm\n  * Platelet: \\>1.5Lakh per cumm\n* Liver functions and kidney functions within normal limits\n* Nutritional and dental assessment before inclusion into the study\n\nExclusion Criteria:\n\n* HPV (p16) positive tumours\n* Prior surgery and\u002For radiation therapy given for any HNC\n* T1\u002FT2 Glottis\n* Metastatic disease or disease not amenable for definitive locoregional treatment.\n* Medical co-morbidity hampering the administration of radiation and\u002For chemotherapy (cisplatin)\n* Pregnancy or lactation","ALL","18 Years","70 Years",{"count":103,"type":104},124,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","DE-HyART is a phase II clinical trial aimed at understanding the effects of escalating radiation doses to hypoxic sub-volumes inherent to squamous cell head and neck cancer. The study is aimed at assessing locoregional control, feasibility, and acceptable toxicity with such a strategy.",[110],"Head and Neck Squamous Cell Carcinoma","2025-01-16",{"date":113,"type":114},"2025-01-17","ACTUAL",{"date":116,"type":114},"2024-04-08",{"date":118,"type":104},"2028-04",{"name":5,"class":6},1]