[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369955":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":54,"overallOfficials":60,"centralContacts":67,"locations":76,"responsibleParty":96,"collaborators":98,"id":102,"slug":39,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":39,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":39,"enrollmentInfo":110,"targetDuration":39,"studyType":113,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":79,"whyStopped":39,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"University Hospital Muenster","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Response rate","4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)","Until 6 months after end of treatment",[14,17,20,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":12},"QoL #1","According to QLQ C30 (EORTC)",{"measure":18,"description":19,"timeFrame":12},"QoL #2","According to STO22 (EORTC)",{"measure":21,"description":22,"timeFrame":23},"EFS","Event-free survival (time to any failure or death from any cause, patients in CR or PR)","Until at least 6 months after end of treatment",{"measure":25,"description":26,"timeFrame":23},"LSS","Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)",{"measure":28,"description":29,"timeFrame":23},"PFS","Progression-free survival (time to progression of lymphoma or death from any cause, all patients)",{"measure":31,"description":32,"timeFrame":23},"OS","Overall survival (time to death from any cause, all patients)",{"measure":34,"description":35,"timeFrame":12},"Level of cytokines in blood serum","IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins",{"measure":37,"description":38,"timeFrame":23},"Acute and chronic toxicities","Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC\u002F LENT-SOMA",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","* Prove the effectiveness of 20 Gy (and non-inferiority to actually recommended 30 Gy) with respect to response rate 6 months after radiotherapy.\n* Correlation of blood serum biomarker levels with lymphoma response to radiation treatment\n* Recording of survival rates, quality of life (QoL), radiogenic toxicities and inflammation relevant molecules in blood serum.\n\nPrimary Objective:\n\nResponse rate 6 months after end of treatment, 4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)\n\nSecondary Objectives:\n\nQoL according to EORTC (QLQ C30 and STO22). EFS=Event-free survival (time to any failure or death from any cause, patients in CR or PR), LSS=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, all patients), OS=overall survival (time to death from any cause, all patients). Level of cytokines IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins. Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC\u002F LENT-SOMA.\n\nMonitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)\n\n-Assessment of safety: Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Treatment (low-dose radiation therapy)","EXPERIMENTAL","Patients undergo low-dose radiation therapy with daily 2 Gy ad 20 Gy (ISRT with IMRT \\& IGRT).\n\nBlood draw for biomarker-analysis (at baseline visit\u002F after 4 Gy\u002F after 10 Gy \u002F after 20 Gy RT\u002F at 3 and 6 months after RT)",[53],"Radiation: Radiation Therapy",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":39},"RADIATION","Radiation Therapy","Low dose radiotherapy with 20 Gy (10x2Gy)",[49],[61,65],{"name":62,"affiliation":63,"role":64},"Prof. Dr. H. Th. Eich","Department of Radiation Oncology University Hospital Muenster","PRINCIPAL_INVESTIGATOR",{"name":66,"affiliation":63,"role":64},"Priv. Doz. Dr. G. Reinartz",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":39,"email":72},"Gabriele Reinartz, MD (Priv. Doz.)","CONTACT","+492518347358","gabriele.reinartz@ukmuenster.de",{"name":74,"role":70,"phone":71,"phoneExt":39,"email":75},"Tina Fischer","tina.fischer@ukmuenster.de",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Department of Radiation Oncology","RECRUITING","Münster","North Rhine-Westphalia","48149","Germany","DE",{"type":86,"coordinates":87},"Point",[88,89],7.62571,51.96236,{"lat":89,"lon":88},[92,93],{"name":69,"role":70,"phone":71,"phoneExt":39,"email":72},{"name":94,"role":70,"phone":71,"phoneExt":39,"email":95},"Stephan Rehn, MD","stephan.rehn@ukmuenster.de",{"type":97,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[99],{"name":100,"class":101},"International Lymphoma Radiation Oncology Group (ILROG)","UNKNOWN","100369955",false,"NCT04097067","ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma","Phase II Trial to Assess the Efficacy of Low Radiation Dose of 20 Gy for the Treatment of Marginal Zone Lymphoma or Follicular Lymphoma Stage I-II Localized in the Stomach or the Duodenum","Inclusion Criteria:\n\n* primary indolent gastric or duodenal lymphoma\n* pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)\n* stage: clinical stage I or II (Ann Arbor classification)\n* H. pylori negative or antibiotic resistant lymphoma\n* IPI or FLIPI score low - high (0-4)\n* any size of tumor or affected lymph nodes\n* male or female with age ≥ 18 years\n* performance status ECOG 0 - 3\n* written informed consent by the patient\n\nExclusion Criteria:\n\n* prior radiation treatment of the gastrointestinal lymphoma\n* stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or unwillingness to participate in the study\n* severe comorbidity or organ dysfunction contraindicating the use of RT (liver cirrhosis Child-Pugh C, chronic obstructive pulmonary disease GOLD 4, heart insufficiency NYHA IV, dialysis dependent renal insufficiency, uncontrolled epilepsy)\n* known seropositivity for HIV\n* acute hepatitis B or C infection\n* chronic inflammatory bowel disease\n* prior malignant disease (exclusion: basalioma, non-metastasized solid tumor in constant remission diagnosed \\>3 years ago)\n* pregnancy or breastfeeding\n* active substance abuse or severely compromised compliance","ALL","18 Years",{"count":111,"type":112},83,"ESTIMATED","INTERVENTIONAL",[41],"This trial studies the effectivity of low-dose radiation therapy with 10x2Gy for the treatment of patients with stage I-II stomach or duodenal Lymphoma (Marginal Zone or Follicular)",[117,118],"Follicular Lymphoma (Gastric or Duodenal)","Marginal Zone Lymphoma (Gastric or Duodenal)",[120,121,122,123,124,125,126,127,128,129,130],"Lymphoma","Lymphoma, B-Cell, Marginal Zone","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Lymphoma, B-Cell","Lymphoma, Non-Hodgkin","Lymphoma, follicular","2024-08-26",{"date":133,"type":134},"2024-08-27","ACTUAL",{"date":136,"type":134},"2019-09-01",{"date":138,"type":112},"2025-08-31",{"name":5,"class":6},1]