[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100327722":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":35,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":78,"collaborators":20,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":20,"eligibilityCriteria":85,"healthyVolunteers":82,"sex":86,"minAge":87,"maxAge":20,"enrollmentInfo":88,"targetDuration":20,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":20,"overallStatus":62,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).","The primary endpoint is IFN-gamma cytokine expression at Day 30 (+\u002F- 2) collection compared to the pre-radiation level. It will be analyzed using generalized linear mixed models.","2 years",{"measure":14,"description":15,"timeFrame":12},"Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy","The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v4.0 \\> or = grade 3 (Increase of \\>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL). This will be evaluated during treatment and at 1 month, 3 months, 6 months and 12 months.",{"measure":17,"description":18,"timeFrame":19},"Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation","Safety Trial: The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v5.0 \\> or = grade 3 Increase of \\>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL). This will be evaluated weekly during vancomycin use and RT, at 1 month post-vancomycin, 3 months post-vancomycin, 6 months post-vancomycin and 12 months post-vancomycin.","3 years",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28],{"label":29,"type":30,"description":31,"interventionNames":32},"Arm 1 - Experimental","EXPERIMENTAL","Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.",[33,34],"Drug: Vancomycin","Radiation: Precision hypofractionated radiation",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":20},"DRUG","Vancomycin","125 mg, 4x daily for 5 weeks",[29],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":20},"RADIATION","Precision hypofractionated radiation","Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression and will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.",[29],[47],{"name":48,"affiliation":49,"role":50},"Steven Feigenberg, MD","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Ching Lai","CONTACT","267-250-9244","ching.lai@pennmedicine.upenn.edu",{"name":58,"role":54,"phone":20,"phoneExt":20,"email":59},"RadOnc Clinical Research Unit","radonccru@pennmedicine.upenn.edu",[61],{"facility":49,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-75.16362,39.95238,{"lat":72,"lon":71},[75,76,77],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},{"name":58,"role":54,"phone":20,"phoneExt":20,"email":59},{"name":48,"role":50,"phone":20,"phoneExt":20,"email":20},{"type":79,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100327722","phase-1-safety-trial-of-antimicrobial-therapy-and-precision-radiation-therapy-in-patients-with-oligoprogressive-non-small-cell-lung-cancer-100327722",false,"NCT03546829","Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer","Randomized Pilot Inclusion\n\n* Patients planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven or clinically-suspected NSCLC\n* Age \\>18 years' old\n* Patient capable of giving informed consent\n\nRandomized Pilot Exclusion\n\n* Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration\n* Active infection with oral temperature \\>100°F\n* Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration\n* Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).\n* Documented history of HIV, HBV or HCV\n* Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate\u002Fsevere irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori infection (untreated)\n* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time\n* Patients on anti-diarrheal medications\n* Patients on probiotics\n\nSafety Trial Inclusion\n\n* Patients planned to receive precision hypofractionated radiation (SBRT or an ablative dose of radiation is used if SBRT is not appropriate or if insurance does not approve - i.e. \\> 30 Gy in 10 fraction equivalent) to all sites of oligoprogressive NSCLC who progressed after 1st line systemic therapy for metastatic disease which included immunotherapy or a tyrosine kinase inhibitors (TKI) for NSCLC\n* The number of sites of progression are \\\u003C 5 sites.\n* Age \\>18 years' old\n* Patient capable of giving informed consent\n\nSafety Trial Exclusion\n\n* Evidence of untreated CNS or leptomeningeal disease\n* Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration\n* Active infection with oral temperature \\>100°F\n* Use of oral corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration\n* Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S3).\n* Documented history of HIV, HBV or HCV\n* Patients on daily anti-diarrheal medications\n* Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy","ALL","18 Years",{"count":89,"type":90},10,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","The first phase of this study was an open label, randomized pilot study. Enrollment for this phase is now complete.\n\nThe second phase is a single arm phase 1 safety study. Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.",[96],"Early Stage Non-Small Cell Lung Cancer","2026-01-13",{"date":99,"type":100},"2026-01-14","ACTUAL",{"date":102,"type":100},"2019-03-05",{"date":104,"type":90},"2028-12-31",{"name":5,"class":6},1]