[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100283076":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tata Memorial Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Arm","ACTIVE_COMPARATOR","45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)\u002F Involved Site Radiotherapy (ISRT)",[13],"Radiation: Standard Arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental Arm","EXPERIMENTAL","36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)\u002F Involved Site Radiotherapy (ISRT)",[19],"Radiation: Experimental Arm",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.",[15],[30],{"name":31,"affiliation":32,"role":33},"Jayant Sastri Goda, M.D","Professor,Tata Memorial Centre","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","919930004414","godajayantsastri@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Sangeeta kakoti, M.D","9769938230","drsangeeta84@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Tata Memorial Center","RECRUITING","Mumbai","Maharashtra","400012","India","IN",{"type":53,"coordinates":54},"Point",[55,56],72.88261,19.07283,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":61,"phoneExt":25,"email":38},"Jayant Goda, M.D.","9930004414",{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jayant Sastri Goda","Associate Professor","100283076","radiation-dose-optimization-in-diffuse-large-b--cell-lymphoma-100283076",false,"NCT02964858","Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.","Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.","DOBL","Inclusion Criteria:\n\n* Histological Diagnosis of NHL- DLBCL.\n* Eligible for RT after R-CHOP.\n* ECOG 0-3.\n* 18 - 65 years.\n* Stage I-IV.\n* Patients should receive at least 4 cycles of R-CHOP chemotherapy.\n* Patients with all extranodal disease except the ones mentioned in the exclusion criteria.\n* Able to understand and willing to provide informed consent for participation in the trial.\n\nExclusion Criteria:\n\n* HIV positive status.\n* Relapse or progression of disease during chemotherapy.\n* Prior history of chemotherapy\n* Prior history of radiotherapy.\n* Systemic lymphomas with CNS involvement.\n* Primary extranodal Testicular Lymphomas.\n* Primary extranodal central nervous system (CNS) Lymphomas.\n* Primary extranodal Stomach DLBCL\n* Primary extranodal Intestinal DLBCL\n* Patients \\>3 extranodal sites","ALL","18 Years","65 Years",{"count":77,"type":78},840,"ESTIMATED","INTERVENTIONAL",[81],"NA","The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions.\n\nThe role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.",[84],"NonHodgkin Lymphoma",[86,87,88,89,90],"Radiation Dose","Optimization","NHL","DLBCL","R-CHOP","2025-04-08",{"date":93,"type":94},"2025-04-11","ACTUAL",{"date":96,"type":25},"2016-11",{"date":98,"type":78},"2027-11",{"name":5,"class":6},1]