[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657312":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":41,"armGroups":46,"interventions":65,"overallOfficials":164,"centralContacts":41,"locations":41,"responsibleParty":168,"collaborators":41,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":41,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":178,"maxAge":41,"enrollmentInfo":179,"targetDuration":41,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":41,"overallStatus":190,"whyStopped":41,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},{"fullName":5,"class":6},"NRG Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","The primary analysis of PFS will be conducted in the intent-to-treat population, defined as all randomized patients. The distributions of PFS will be estimated by the Kaplan-Meier method. The primary comparison between arms will use a one-sided stratified log-rank test with the randomization stratification factors. A stratified Cox proportional hazards model will be used to estimate the hazard ratio and corresponding confidence interval. An unstratified log-rank test and unstratified Cox proportional hazards model will also be provided as sensitivity analyses. No post hoc modification or collapsing of stratification categories based on observed event counts will be performed. If the stratified Cox model is not estimable because of sparse data, the unstratified Cox model will be used to summarize the treatment hazard ratio and confidence interval, with the reason documented.","From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 5 years",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Overall survival","Will be summarized using Kaplan-Meier methods. Comparisons between arms will be summarized descriptively using hazard ratio estimates and corresponding confidence intervals.","From randomization to death from any cause, assessed up to 5 years",{"measure":19,"description":20,"timeFrame":21},"Incidence of clinician-scored treatment-related adverse events","Clinician-scored adverse events will be summarized by study arm using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). For each patient, the maximum severity reported for each adverse event will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. All adverse events, adverse events leading to withdrawal, interruption or modification of protocol treatment, Grade ≥ 3 adverse events, and serious adverse events will be summarized. Deaths and cause of death will be summarized. Event summaries will be presented by type, grade, and attribution and will be performed at the time of the primary endpoint analysis.","Up to 5 years",{"measure":23,"description":24,"timeFrame":21},"Incidence of patient-reported adverse events","A composite grading algorithm (Basch 2021) will be utilized to derive a single numerical grade for each adverse event scored at each timepoint using Patient-Reported Outcomes (PRO)-CTCAE. Patient-reported adverse events measured using PRO-CTCAE will also be summarized descriptively by arm and time point, together with compliance and missing-data patterns.",{"measure":26,"description":27,"timeFrame":21},"Site of first disease progression","Patterns of first failure will be summarized descriptively by arm using the categories specified in the protocol, including locoregional\u002Fintrathoracic progression, distant progression, or both. Formal hypothesis testing for these secondary endpoints is not planned unless otherwise specified in a future statistical analysis plan.",[29,32,35],{"measure":30,"description":31,"timeFrame":21},"Clinical and dosimetric predictors of high-grade treatment-related toxicity","These analyses will be restricted to patients who initiate protocol reirradiation and will be descriptive and hypothesis-generating. Candidate predictors may include baseline clinical characteristics, prior treatment characteristics, and dosimetric parameters from the reirradiation and composite treatment plans. Associations with high-grade treatment-related toxicity will be summarized using appropriate descriptive and regression-based methods, as feasible given the number of observed events.",{"measure":33,"description":34,"timeFrame":21},"Radiotherapy modality toxicity and efficacy outcomes","Will include descriptive comparisons of toxicity and efficacy outcomes, including time-to-event outcomes and treatment-related adverse events, among patients treated with proton versus photon radiotherapy within Arm 2. Because radiotherapy modality is selected by the treating team and not randomized within Arm 2, these analyses will be considered descriptive and hypothesis-generating only.",{"measure":36,"description":37,"timeFrame":21},"Regional lung ventilation metrics","Among Arm 2 patients with available four-dimensional computed tomography planning scans, additional exploratory analyses may derive regional lung ventilation metrics and evaluate their association with pulmonary toxicity. These analyses are intended to identify potential imaging-based predictors of pulmonary toxicity and to generate hypotheses for future study.",{"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","PRIMARY OBJECTIVE:\n\nI. In patients with NSCLC who develop locoregional disease recurrence after thoracic radiotherapy, to compare progression-free survival outcomes following curative-intent reirradiation versus systemic therapy alone.\n\nSECONDARY OBJECTIVES:\n\nI. To compare overall survival outcomes across study arms. II. To compare clinician-scored adverse events, scored using Common Terminology Criteria for Adverse Events (CTCAE), across study arms.\n\nIII. To compare patient-reported adverse events, scored using Patient-Reported Outcomes (PRO)-CTCAE, across study arms.\n\nIV. To compare patterns of disease progression across study arms.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate clinical and dosimetric predictors of high-grade treatment-related toxicity within the experimental study arm.\n\nII. To compare the toxicity and efficacy of proton beam radiotherapy versus photon radiotherapy within the experimental study arm.\n\nIII. To calculate regional lung ventilation using four-dimensional (4D) computed tomography (CT) planning scans and evaluate associated predictors of pulmonary toxicity.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 1: Patients receive standard of care (SOC) systemic therapy, which may include chemotherapy, immunotherapy, and\u002For targeted therapy on study. Patients also undergo positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and magnetic resonance imaging (MRI) during screening, as well as chest CT and optional blood sample collection throughout the study.\n\nARM 2: Patients undergo radiation therapy (RT) for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET\u002FCT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up periodically until 5 years.",[47,58],{"label":48,"type":49,"description":50,"interventionNames":51},"Arm 1 (SOC systemic therapy)","ACTIVE_COMPARATOR","Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and\u002For targeted therapy on study. Patients also undergo PET\u002FCT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.",[52,53,54,55,56,57],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Other: Immunotherapy","Procedure: Magnetic Resonance Imaging","Drug: Systemic Chemotherapy","Other: Targeted Therapy",{"label":59,"type":60,"description":61,"interventionNames":62},"Arm 2 (repeat RT, chemotherapy)","EXPERIMENTAL","Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET\u002FCT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.",[52,53,55,63,64,56],"Procedure: Positron Emission Tomography","Radiation: Radiation Therapy",[66,76,93,101,121,133,151,156],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[48,59],[72,73,74,75],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":67,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Computed Tomography","Undergo PET\u002FCT and\u002For chest CT",[48,59],[81,82,83,84,85,86,87,88,89,90,91,92],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":6,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"Immunotherapy","Given SOC immunotherapy",[48],[98,99,100],"Immunological","Immunological Therapy","Immunologically Directed Therapy",{"type":67,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Magnetic Resonance Imaging","Undergo MRI",[48,59],[106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":67,"name":122,"description":123,"armGroupLabels":124,"otherNames":125},"Positron Emission Tomography","Undergo PET\u002FCT",[59],[126,127,128,129,130,131,132],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":134,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"RADIATION","Radiation Therapy","Undergo repeat RT",[59],[139,140,141,142,143,144,145,146,147,148,149,150],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":152,"name":153,"description":154,"armGroupLabels":155,"otherNames":41},"DRUG","Systemic Chemotherapy","Given SOC chemotherapy",[48,59],{"type":6,"name":157,"description":158,"armGroupLabels":159,"otherNames":160},"Targeted Therapy","Given SOC targeted therapy",[48],[161,162,163],"Target\u002FMechanism","Targeted","Targeting Therapy",[165],{"name":166,"affiliation":5,"role":167},"Nitin Ohri","PRINCIPAL_INVESTIGATOR",{"type":169,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100657312","phase-2-testing-repeat-radiation-therapy-for-recurrent-non-small-cell-lung-cancer-100657312",false,"NCT07835789","Testing Repeat Radiation Therapy for Recurrent Non-small Cell Lung Cancer","A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry\n* Participants must have recurrent\u002Fprogressive disease in the lung and\u002For regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry\n* Biopsy to confirm recurrent\u002Fprogressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required\n* A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan\n* New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted\n* Participants must not have definitive clinical or radiographic evidence of distant metastatic NSCLC at present or in the past\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Not Pregnant and Not Nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Prior thoracic radiotherapy for NSCLC must have been delivered as definitive treatment, as opposed to in the preoperative or postoperative setting. One prior radiotherapy course must meet the specifications, and the radiotherapy plan from that course must be available in Digital Imaging and Communications in Medicine (DICOM) format\n* Patients who have received additional prior radiotherapy (i.e., more than one prior radiotherapy course) may be enrolled, provided that only one prior radiotherapy course is deemed to affect the risks associated with treatment with radiotherapy on this study. As examples, prior radiotherapy for an extrathoracic malignancy would likely not affect the risks associated with reirradiation on this study. Prior radiotherapy for breast cancer may be permissible, depending on the extent of lung irradiation. Similarly, prior SBRT for a peripheral lung tumor may be permissible\n* No prior SBRT for a central lung tumor, hilar lymph node, or mediastinal lymph node\n* Prior lobar and sublobar lung resections are allowed, but prior pneumonectomy is not allowed\n* Prior chemotherapy, targeted therapy, and\u002For immunotherapy for lung cancer is allowed\n* No history of CTCAE version (v.) 5.0 grade 2-4 RT pneumonitis or ongoing CTCAE v. 5.0 grade 2-4 pneumonitis from any cause\n* No clinically significant interstitial lung disease","ALL","18 Years",{"count":180,"type":181},138,"ESTIMATED","INTERVENTIONAL",[184],"PHASE2","This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.",[187,188,189],"Locally Recurrent Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","NOT_YET_RECRUITING","2026-09-17",{"date":193,"type":194},"2026-09-23","ACTUAL",{"date":196,"type":181},"2026-12-18",{"date":198,"type":181},"2034-09-30",{"name":5,"class":6}]