[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04115254":3,"trial-entities:NCT04115254":166,"trial-summary:NCT04115254":175},{"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":32,"study_type":41,"primary_purpose":42,"phases":43,"enrollment_info":45,"interventions":48,"primary_outcomes":73,"secondary_outcomes":88,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":112,"eligibility_criteria":113,"std_ages":128,"locations":131,"central_contacts":153,"overall_officials":157,"references":160,"see_also_links":165},"NCT04115254","19-353","Stereotactic Magnetic Resonance Guided Radiation Therapy","A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)","RECRUITING","2028-06","2025-11","2025-11-13","2019-10-22","Dana-Farber Cancer Institute","OTHER",true,"This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.\n\n* The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.\n* Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures","This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.\n\nThe U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.\n\nIn this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.",[19,20,21,22,23,24,25,26,27,28,29,30,31],"Pancreas Cancer","Lung Cancer","Renal Cancer","Adrenal Metastases","Prostate Cancer","Liver Metastases","Oligoprogressive Nodal Metastases","Metachronous Nodal Metastases","Synchronous Nodal Metastases","Mesothelioma","Spine Metastases","Brain Metastases","Borderline Resectable Pancreatic Carcinoma",[33,34,19,20,21,22,23,24,35,36,37,38,39,40],"Magnetic Resonance Imaging (MRI)","MRIdian Linear Accelerator","Oligoprogressive","Metachronous","Synchronous","Spine","Prostate Boost","Pelvic Re Irradiation","INTERVENTIONAL","TREATMENT",[44],"NA",{"count":46,"type":47},397,"ESTIMATED",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53},"RADIATION","MR-guided Linac","Radiation will be delivered on an MR-guided Linear Accelerator",[54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--1\u002F3 Fraction for Oligometastatases in the Abdomen\u002FPelvis","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Adrenal Metastases","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Borderline Resectable Pancreas","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Brain Metastases","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Central Lung","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Liver Metastases","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Mediastinal and Hilar Lymph Nodes","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Mesothelioma","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Metachronous Oligometastatic Nodes","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Oligoprogressive Oligometastatic Nodes\u002FSoft Tissue","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Pancreatic","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Pelvic Re-Irradiation","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Post-Operative Radiation Therapy in Lung Cancer","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Prostate","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Prostate Boost","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Renal","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Single-Fraction Kidney Tumors","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Spine","PHASE 1: SBRT MR IMAGE GUIDANCE\u002FADAPTATION--Synchronous Oligometastatic Nodes\u002FSoft Tissue",[74,78,82,85],{"measure":75,"description":76,"timeFrame":77},"Delivery Success Rate for SMART across multiple tumors-Phase I","Enrolling patients and delivering SMART on the MR Linac","1 year",{"measure":79,"description":80,"timeFrame":81},"Tumor visualization-Phase I","Assessing tumor using MR guidance before, during and after MR-guided treatment patient","1 Year",{"measure":83,"description":84,"timeFrame":81},"Plan creation-Phase I","Generating adaptive plans",{"measure":86,"description":87,"timeFrame":81},"Rate of Improvement in Tumor Control-Phase II","Statistical power will be defined in each cohort individually and will be specific to each disease site tested.",[89,93,96,99,103,106],{"measure":90,"description":91,"timeFrame":92},"Number of Patients with Acute Toxicity-Phase I","Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART","90 Days",{"measure":94,"description":95,"timeFrame":92},"Duration of treatment-Phase 1","Duration of treatment with goal of \\>80% of cases treated within 90 minutes",{"measure":97,"description":98,"timeFrame":92},"Number of treatment fractions-Phase1","Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART",{"measure":100,"description":101,"timeFrame":102},"Number of Participants with long term toxicity-Phase II","assessing long-term (12 month) toxicity in patients receiving SMART","365 Days",{"measure":104,"description":105,"timeFrame":102},"Disease Specific Survival Rate-Phase II","Kaplan-Meier curve estimates",{"measure":107,"description":105,"timeFrame":108},"Overall Survival Rate-Phase II","365","ALL","18 Years",null,false,{"inclusion":114,"exclusion":121,"raw_text":127},[115,116,117,118,119,120],"Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.","Tumor size ≤ 7cm","Age 18 years of older.","ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)","Ability to understand and the willingness to sign a written informed consent document.","Specific eligibility requirements for each disease site with be covered in each specific cohort.",[122,123,124,125,126],"Specific exclusion requirements for each disease site with be covered in each specific cohort","History of allergic reactions attributed to gadolinium-based IV contrast.","Pregnant women are excluded from this study.","Severe claustrophobia or anxiety","Participants who cannot undergo an MRI","Inclusion Criteria:\n\n* Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.\n* Tumor size ≤ 7cm\n* Age 18 years of older.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Specific eligibility requirements for each disease site with be covered in each specific cohort.\n\nExclusion Criteria:\n\n* Specific exclusion requirements for each disease site with be covered in each specific cohort\n* History of allergic reactions attributed to gadolinium-based IV contrast.\n\n  \\-- Note: If a patient will not receive contrast, this is not applicable\n* Pregnant women are excluded from this study.\n* Severe claustrophobia or anxiety\n* Participants who cannot undergo an MRI",[129,130],"ADULT","OLDER_ADULT",[132,147],{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":137,"contacts":138,"geoPoint":144},"Brigham & Women's Hospital","Boston","Massachusetts","02115","United States",[139,142],{"name":140,"role":141},"Jonathan Leeman, MD","CONTACT",{"name":140,"role":143},"PRINCIPAL_INVESTIGATOR",{"lat":145,"lon":146},42.35843,-71.05977,{"facility":148,"status":8,"city":134,"state":135,"zip":136,"country":137,"contacts":149,"geoPoint":152},"Dana Farber Cancer Institute",[150,151],{"name":140,"role":141},{"name":140,"role":143},{"lat":145,"lon":146},[154],{"name":140,"role":141,"phone":155,"email":156},"617-732-6452","JONATHANE_LEEMAN@DFCI.HARVARD.EDU",[158],{"name":140,"affiliation":159,"role":143},"Brigham and Women's Hospital",[161],{"pmid":162,"type":163,"citation":164},"40794880","DERIVED","Leeman JE, Shin KY, Droznin A, Catalano P, Cagney DN, Singer L, Oniyangi RD, Zhai K, Benham G, Chirmade S, Campbell J, Boyle S, Saranteas A, Williams CL, Huynh E, Han Z, Sudhyadhom A, Hu YH, Ferguson D, Singhrao K, Hsu SH, Bredfeldt J, Martin NE, Mancias JD, Mamon HJ, Van Dams R, Venkatachalam V, Tanguturi SK, Huynh MA, Fitzgerald KJ, Elhalawani H, Bitterman DS, Schoenfeld JD, Nguyen P, Haas-Kogan DA, Mak R. Stereotactic magnetic resonance imaging-guided adaptive radiotherapy: a pooled analysis of a master prospective trial. J Natl Cancer Inst. 2025 Nov 1;117(11):2289-2297. doi: 10.1093\u002Fjnci\u002Fdjaf208.",[],{"nct_id":4,"conditions":167,"biomarkers":174},[168,169,170,171,172,173],"Kidney Carcinoma","Lung Carcinoma","Mesothelial Neoplasm","Pancreatic Carcinoma","Prostate Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":176,"prompt_version":186},{"design":177,"status":178,"heading":179,"summary":180,"follow_up":181,"word_count":182,"commitments":183,"compensation":184,"drugs_mentioned":185},"This is a Phase I-II interventional study, meaning it's testing a new treatment. It aims to enroll 397 participants.","completed","Stereotactic MR-Guided Radiation Therapy for Various Cancers","This study is testing a new way to deliver radiation therapy called Stereotactic Magnetic Resonance Guided Radiation Therapy (SMART) using an MR-guided Linear Accelerator. This is a first-time evaluation at this institution to see if adjusting radiation treatments daily based on MRI is a practical way to treat pancreatic, lung, or kidney cancer. The study is open to adults aged 18 and older with certain cancers (pancreas, lung, kidney, adrenal metastases, prostate) that require stereotactic body radiation therapy, and whose tumor is 7cm or smaller. The main goals are to see how successfully the radiation can be delivered, how well the tumor can be seen, and how easily treatment plans can be created, all measured at 1 year.","The primary endpoints are measured at 1 year after treatment.",118,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]