[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435611":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":52,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"AHS Cancer Control Alberta","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose-escalated adaptive chemoradiotherapy","EXPERIMENTAL","Concurrent with standard of care platinum doublet based chemotherapy (cisplatin + etoposide), radiation treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk: Phase 1 dose prescription = 14 Gy in 7 fractions; Phase 2 dose prescription = 10 Gy in 5 fractions starting the day after the final (7th) fraction is delivered; Phase 3 dose prescription = either a) 70 Gy in 35 fractions, or if this cannot be safely reached without exceeding the dose limit of an organ-at-risk, b) the maximum safe prescribe-able dose tolerance specified in the protocol. Either 3D conformal radiotherapy or IMRT planning and delivery techniques will be employed, including contouring relevant thoracic organs-at-risk. All CT simulation scans will be without contrast.",[13,14],"Radiation: Dose-escalated adaptive radiotherapy","Drug: Chemotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Dose-escalated adaptive radiotherapy","Adaptive planning of Radiation Therapy with two re-plans of the treatment field through course of therapy with the shrinking treatment fields according to tumor response to escalate dose, as allowed by dose to organs-at-risk.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Chemotherapy","Concurrent standard of care platinum doublet based therapy",[9],[28],{"name":29,"affiliation":30,"role":31},"Yee Don, MD","Cross Cancer Institute, Alberta Health Services","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":21,"email":36},"CONTACT","780-432-8783","don.yee@ahs.ca",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":21},"Cross Cancer Institute","RECRUITING","Edmonton","Alberta","T6G 1Z2","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-113.46871,53.55014,{"lat":50,"lon":49},{"type":53,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100435611","phase-2-dose-escalated-adaptive-radiotherapy-of-thoracic-disease-for-small-cell-lung-cancer-100435611",false,"NCT04952480","Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer","Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer (DARTS): A Prospective Phase II Trial Evaluating Local Control of Adaptive Dose-escalated Radiotherapy","DARTS","Inclusion Criteria:\n\n* Minimum 18 years of age\n* Biopsy proven, newly diagnosed, untreated SCLC\n* Completed standard of care staging investigations including: CT chest\u002Fabdomen\u002Fpelvis, bone scan and\u002For or PET-CT scan, CT head or MRI brain, or chest X-ray\n* Eligible for platinum doublet chemotherapy\n* Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease\n* Capable of providing written, informed consent prior to participation in the study. Patient's legally authorized representative (LAR) may sign on behalf of the patient.\n* Able and willing to comply with protocol rules and follow-up regimen\n* Performance status of ECOG 0-2\n* Pulmonary function tests showing FEV-1 \\>1.0L and DLCO \\> 50% predicted\n* Radiation-targetable intrathoracic disease\n\nExclusion Criteria:\n\n* No intrathoracic disease seen to target with radiation\n* Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes\n* Mixed histology disease\n* Active serious infection requiring therapy\n* Brain metastasis that has not been symptomatically stable on dexamethasone\n* 4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system\n* Previous CNS or thoracic radiotherapy\n* Previous chemotherapy\n* Ineligibility for platinum doublet chemotherapy\n* Life expectancy of less than 3 months\n* Prior thoracic surgery\n* History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years\n* Pregnant or breast-feeding\n* In LS-SCLC, patients that are not eligible for concurrent chemoradiotherapy\n* In ES-SCLC, patients that are not eligible for concurrent chemoradiotherapy under the experimental arm\n* CT contrast allergy or kidney disease with irreversibly low creatinine clearance inadequate for IV contrast administration (for the purposes of high quality contrast enhanced CT chest and abdomen for follow-up imaging)\n* Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy\n* Participant in development and conduct of the research study","ALL","18 Years",{"count":65,"type":66},31,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.",[72],"Small Cell Lung Cancer",[74,75],"Small cell lung cancer","(Dose-escalated) Adaptive radiotherapy","2025-06-10",{"date":78,"type":79},"2025-06-12","ACTUAL",{"date":81,"type":79},"2022-06-13",{"date":83,"type":66},"2025-11-01",{"name":5,"class":6},1]