[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522822":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":41,"armGroups":46,"interventions":66,"overallOfficials":90,"centralContacts":95,"locations":101,"responsibleParty":123,"collaborators":126,"id":130,"slug":41,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":69,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":41,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":41,"overallStatus":103,"whyStopped":41,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Rajiv Gandhi Cancer Institute & Research Center, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Locoregional Control (LRC)","LRC is defined as the absence of tumor recurrence or progression within the primary tumor site and the regional lymph nodes, as determined by clinical evaluation, imaging studies, and\u002For biopsy confirmation. LRC will be assessed at predefined time points, with the primary time point being 2 years post-treatment","Disease recurrence locally or analysis cut-off point. The analysis cut off pint is 24 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"Overall Survival (OS)","The duration of OS was defined from the date of surgery to death from any cause. Therefore, if there is no death (for any reason), the OS duration will be cut-off at the analysis.","Death during following up or analysis cut-off point. The analysis cut off pint is 24 months",{"measure":19,"description":20,"timeFrame":21},"Locoregional Relapse Free Survival (LRFS)","LRFS is defined as the time from the date of randomization to the first histopathologically confirmed relapse of locoregional disease. If there is no confirmed recurrence, the LRC duration will be censored at the time of analysis. Death from any cause will be considered as an event in LRFS.","Disease\u002FDeath during following up or analysis cut-off point. The analysis cut off pint is 24 months",[23,27,31,35],{"measure":24,"description":25,"timeFrame":26},"Acute toxicity","The acute toxicity will be measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0","Till 6 months of finishing radiotherapy",{"measure":28,"description":29,"timeFrame":30},"Late toxicity assessment","Measuring scale: (RTOG\u002FEuropean Organisation for the Research and Treatment of Cancer late toxicity criteria)","At 1 year and 2 year follow-up",{"measure":32,"description":33,"timeFrame":34},"Patient-reported outcome questionnaire","EORTC QLQ-C30","During treatment, at 3 month and 6 month interval of completion of radiotherapy",{"measure":36,"description":37,"timeFrame":34},"Patient-reported outcome QLQ-HN35 questionnaire","QLQ-H\\&N35",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE","DE-HyART is a randomized, non-blinded study that assesses the effects of combining IMRT (using SIB-Sequential planning) with dose-escalation to hypoxic sub-volume delineated using \\[18-F\\] FMISO. The treatment protocol will also include concurrent chemotherapy with cisplatin at standard uniform dosing.\n\nPatients with HNSCC whose cancer is determined to originate from the oral cavity, oropharynx, larynx, and hypopharynx will be selected. The included patients will be subjected to \\[18F\\] FMISO scan, labeled as baseline FMISO. Depending upon the result of the baseline FMISO, the patient will be either hypoxic or anoxic. Patients exhibiting no hypoxia in their tumor will be labeled as Arm 1 and act as an external cohort. Patients with hypoxia will be randomized (1:1) into two arms - Arms 2 and 3. Both arms will be subjected to chemoradiation by IMRT and concurrent chemotherapy with cisplatin at 40mg\u002Fm2. In Arm 3, the trial arm will receive an additional 10 Gy @ 2 Gy per fraction in phase II (total 80 Gy) to the HSV + 5mm isotropic margin.\n\nOne twenty-four patients will recruited in a 1:1 fashion between Arm 3 and Arm 2. The primary endpoint will be locoregional control and its possible increase in control.",[47,54,60],{"label":48,"type":49,"description":50,"interventionNames":51},"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).",[52,53],"Radiation: DE-HyART","Drug: Cisplatin injection",{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59,53],"Radiation: Standard Arm",{"label":61,"type":62,"description":63,"interventionNames":64},"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.",[53,65],"Radiation: Standard fractionation (Radiation Oncology preference)",[67,76,81,86],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"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.",[48],[73,74,75],"Dose escalated radiotherapy","Hypoxic sub volume","FMISO",{"type":68,"name":77,"description":57,"armGroupLabels":78,"otherNames":79},"Standard Arm",[55],[80],"Standard Sequential fractionation without dose escalation",{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":41},"DRUG","Cisplatin injection","Concurrent chemotherapy, weekly Inj Cisplatin 40mg\u002Fm2. This will be given if clinically indicated",[61,55,48],{"type":68,"name":87,"description":88,"armGroupLabels":89,"otherNames":41},"Standard fractionation (Radiation Oncology preference)","Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks",[61],[91],{"name":92,"affiliation":93,"role":94},"Munish Gairola, MD,DNB Radiation Oncology","Rajiv Gandhi Cancer Institute and Research Centre","PRINCIPAL_INVESTIGATOR",[96],{"name":97,"role":98,"phone":99,"phoneExt":41,"email":100},"Sarthak Tandon, DNB","CONTACT","+911147022009","tandon.sarthak@rgcirc.org",[102],{"facility":93,"status":103,"city":104,"state":41,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"RECRUITING","Delhi","110085","India","IN",{"type":109,"coordinates":110},"Point",[111,112],77.23149,28.65195,{"lat":112,"lon":111},[115,119,121],{"name":116,"role":98,"phone":117,"phoneExt":41,"email":118},"Sarthak Tandon, DNB Radiation Oncology","(+91)11-47022009","drsarthaktandon@yahoo.in",{"name":120,"role":94,"phone":41,"phoneExt":41,"email":41},"Munish Gairola, MD, DNB Radiation Oncology",{"name":116,"role":122,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"type":94,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Munish Gairola","Dr",[127],{"name":128,"class":129},"Varian, a Siemens Healthineers Company","INDUSTRY","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":140,"type":141},124,"ESTIMATED","INTERVENTIONAL",[144],"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.",[147],"Head and Neck Squamous Cell Carcinoma","2025-01-16",{"date":150,"type":151},"2025-01-17","ACTUAL",{"date":153,"type":151},"2024-04-08",{"date":155,"type":141},"2028-04",{"name":5,"class":6},1]