[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718672":3,"trial-entities:NCT07718672":173,"trial-summary:NCT07718672":177},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":95,"secondary_outcomes":100,"sex":124,"minimum_age":125,"maximum_age":126,"healthy_volunteers":15,"eligibility_criteria":127,"std_ages":148,"locations":151,"central_contacts":168,"overall_officials":169,"references":171,"see_also_links":172},"NCT07718672","I-4050824","Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer","(PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2029-09-01","2026-07","2026-07-22","2026-09-01","Roswell Park Cancer Institute","OTHER",false,"This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.","PRIMARY OBJECTIVE:\n\nI. Evaluate the impact of incorporating high isodoses termed \"hot spots\" in radiation therapy planning on local control.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate the impact of \"hot spots\" in radiation therapy planning on progression-free survival (PFS).\n\nII. Evaluate the impact of \"hot spots\" in radiation therapy planning on overall survival (OS).\n\nIII. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner.\n\nIV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients undergoing SABR who are already taking a beta-blocker as well as a potential interaction between beta-blocker usage and the perceived stress scale.\n\nV. Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer \\[EORTC QLQ-LC13\\]) and hotspot grouping.\n\nVI. Evaluate the impact of \"hot spots\" in radiation therapy planning on toxicity by total number of grade 3+ adverse effects.\n\nEXPLORATORY OBJECTIVE:\n\nI. Change in immune cell marker levels at week 12 post-SBRT (± 1 week) versus baseline, such as mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, including CD4+ and CD+8 T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs).\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive standard of care (SOC) SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan with or without positron emission tomography (PET) scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.\n\nARM II: Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.\n\nAfter completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36.",[19,20,21],"Early Stage Lung Non-Small Cell Carcinoma","Stage I Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},200,"ESTIMATED",[31,43,60,66,78,87,91],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[36,37],"Aim II (hot spot SBRT)","Arm I (SOC SBRT)",[39,40,41,42],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Computed Tomography","Undergo CT scan",[36,37],[48,49,50,51,52,53,54,55,56,57,58,59],"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":32,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Lymph Node Biopsy","Undergo lymph node sampling",[36,37],[65],"Biopsy of Lymph Node",{"type":32,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Positron Emission Tomography","Undergo PET scan",[36,37],[71,72,73,74,75,76,77],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"RADIATION","Stereotactic Body Radiation Therapy","Receive SOC SBRT",[37],[84,85,86],"SABR","SBRT","Stereotactic Ablative Body Radiation Therapy",{"type":79,"name":80,"description":88,"armGroupLabels":89,"otherNames":90},"Receive hot spot SBRT",[36],[84,85,86],{"type":14,"name":92,"description":93,"armGroupLabels":94},"Survey Administration","Ancillary studies",[36,37],[96],{"measure":97,"description":98,"timeFrame":99},"Time to progression (local control)","Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.","Up to 2 years",[101,105,109,113,115,118,121],{"measure":102,"description":103,"timeFrame":104},"Progression free survival (PFS)","Will be summarized by treatment arms using the Kaplan-Meier product limit estimator.","From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years",{"measure":106,"description":107,"timeFrame":108},"Overall survival (OS)","Will be summarized by treatment arms using the Kaplan-Meier product limit estimator. One-sided log-rank test stratified by tumor size, performance status, and surgery candidacy will be used to compare the OS between treatment arms (alpha=0.1).","From the start of treatment to patient death due to any cause, up to 3 years",{"measure":110,"description":111,"timeFrame":112},"Time to progression (local control) in a size-dependent manner","Defined as no failure within the radiotherapy PTV, based on the international consensus on assessing local failure after SBRT will be utilized.","Up to 3 years",{"measure":114,"timeFrame":112},"PFS for patients who are already taking a beta blocker",{"measure":116,"description":117,"timeFrame":112},"Perception of Stress using Perceived Stress Scale","Will be measured by The Perceived Stress Scale (PSS) which assesses the perception of stress. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome",{"measure":119,"description":120,"timeFrame":112},"Change in Quality of life","Assessed via European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer.",{"measure":122,"description":123,"timeFrame":112},"Incidence of grade 3+ adverse events","Toxicities and adverse events (as per Common Terminology for Adverse Events version 5.0) will be summarized by the treatment arms, type, incidence, severity, seriousness, and relatedness. The rate of grade ≥ 3 AEs will be summarized as proportions with 90% Clopper Pearson confidence intervals.","ALL","18 Years",null,{"inclusion":128,"exclusion":136,"raw_text":147},[129,130,131,132,133,134,135],"Age ≥ 18 years","Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2","Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation","Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled","Eligible for SABR","Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately","Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure",[137,138,139,140,141,142,143,144,145,146],"Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy","Mixed small cell and non-small cell lung cancer","History of allogeneic organ transplantation","History of primary immunodeficiency","Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment","Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed","Known EGFR or ALK mutation","Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD","Pregnant or nursing female participant","Unwilling or unable to follow protocol requirements","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation\n* Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled\n* Eligible for SABR\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy\n* Mixed small cell and non-small cell lung cancer\n* History of allogeneic organ transplantation\n* History of primary immunodeficiency\n* Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment\n* Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Known EGFR or ALK mutation\n* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD\n* Pregnant or nursing female participant\n* Unwilling or unable to follow protocol requirements",[149,150],"ADULT","OLDER_ADULT",[152],{"facility":13,"city":153,"state":154,"zip":155,"country":156,"contacts":157,"geoPoint":165},"Buffalo","New York","14263","United States",[158,163],{"name":159,"role":160,"phone":161,"email":162},"Mark Farrugia","CONTACT","716-845-1179","Mark.Farrugia@RoswellPark.org",{"name":159,"role":164},"PRINCIPAL_INVESTIGATOR",{"lat":166,"lon":167},42.88645,-78.87837,[],[170],{"name":159,"affiliation":13,"role":164},[],[],{"nct_id":4,"conditions":174,"biomarkers":176},[175],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":178,"summary":179,"prompt_version":189},true,{"design":180,"status":181,"heading":182,"summary":183,"follow_up":184,"word_count":185,"commitments":186,"compensation":187,"drugs_mentioned":188},"This interventional study plans to enroll 200 participants. It compares two different ways of delivering radiation therapy.","completed","Stereotactic Ablative Radiotherapy for Early-Stage Lung Cancer","This study is comparing two ways to give stereotactic ablative radiotherapy (SBRT) for early-stage non-small cell lung cancer. One method is standard SBRT, and the other is SBRT with \"hot spots,\" which means the tumor gets a higher radiation dose. Researchers want to see if SBRT with hot spots is better at controlling the tumor, even if it might cause more side effects. You could be eligible if you are at least 18 years old, have early-stage non-small cell lung cancer confirmed by biopsy, and have a good performance status. The main goal is to see how long it takes for the cancer to return (local control) over two years.","The study will measure how long it takes for the cancer to return for up to 2 years.",110,"You would undergo blood sample collection, CT scans, lymph node sampling, PET scans, and receive SBRT radiation treatment.","Not stated in the trial record.",[],"v2"]