[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07708636":3,"trial-entities:NCT07708636":89,"trial-summary:NCT07708636":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":14,"phases":20,"enrollment_info":21,"interventions":24,"primary_outcomes":31,"secondary_outcomes":36,"sex":48,"minimum_age":14,"maximum_age":14,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":56,"locations":60,"central_contacts":83,"overall_officials":85,"references":87,"see_also_links":88},"NCT07708636","IRB-85278","UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy","NOT_YET_RECRUITING","2027-09","2026-07","2026-07-16","2026-09","Stanford University","OTHER",null,"This study is being done to evaluate whether cancer patients can safely and reliably receive proton radiation therapy while positioned upright. Proton therapy is an established form of radiation treatment, and the upright treatment system used in this study has been cleared by the U.S. Food and Drug Administration. The intent of this protocol is to observe the treatment methods, doses, and outcomes for the initial cohorts of patients treated with this upright device. This study will support research activities and evaluate feasibility as needed. Results of this study will be reported in the scientific literature but the investigators do not intend to report to the FDA for a new use or indication or change to the labeling; nor are the investigators required to do so.",[17],"Proton Therapy",[],"OBSERVATIONAL",[],{"count":22,"type":23},450,"ESTIMATED",[25],{"type":26,"name":27,"description":28,"armGroupLabels":29},"RADIATION","Standard-of-Care Proton Therapy","Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.",[30],"Participants Receiving Standard-of-Care Proton Therapy",[32],{"measure":33,"description":34,"timeFrame":35},"Feasibility of upright proton therapy","Feasibility is defined by the proportion of evaluable patients who complete a technically successful course of upright proton therapy. Technically successful course of upright proton therapy is defined as ≥80% of prescribed proton fractions delivered with upright proton therapy. Feasible if ≥70% of evaluable cases meet technically successful criterion.","End of proton therapy (3 months)",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Quality of Life (FACT-G)","Quality of life assessed using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Total score ranges from 0 to 108, with higher scores indicating better quality of life.","Baseline and end of proton therapy (3 months)",{"measure":42,"description":43,"timeFrame":35},"Treatment Satisfaction (FACIT-TS-G)","Treatment satisfaction assessed using the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) questionnaire. Total score ranges from 0 to 21, with higher scores indicating greater treatment satisfaction.",{"measure":45,"description":46,"timeFrame":47},"Comfort\u002FStability Survey at Simulation","Participant-reported comfort and perceived stability during upright and supine simulation, assessed using a custom survey. Total score ranges from 10 to 50, with higher scores indicating better quality of life.","Baseline","ALL",false,{"inclusion":51,"exclusion":54,"raw_text":55},[52,53],"Any cancer patient (children and adults) recommended for proton therapy.","Participation in other clinical trials is allowed (including randomized trials of protons versus other treatments)",[],"Inclusion Criteria:\n\n* Any cancer patient (children and adults) recommended for proton therapy.\n* Participation in other clinical trials is allowed (including randomized trials of protons versus other treatments)\n\nExclusion Criteria:\n\n* Any patient that doesn't meet the inclusion criteria",[57,58,59],"CHILD","ADULT","OLDER_ADULT",[61,78],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":75},"Lucile Packard Children's Hospital Stanford","Palo Alto","California","94304","United States",[68,72],{"name":69,"role":70,"email":71},"Aryan Dwivedi","CONTACT","aryand@stanford.edu",{"name":73,"role":74},"Yuan J Rao, MD","PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},37.44188,-122.14302,{"facility":12,"city":63,"state":64,"zip":65,"country":66,"contacts":79,"geoPoint":82},[80,81],{"name":69,"role":70,"email":71},{"name":73,"role":74},{"lat":76,"lon":77},[84],{"name":69,"role":70,"phone":71,"email":71},[86],{"name":73,"affiliation":12,"role":74},[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Malignant Neoplasm",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study that plans to enroll 450 participants. It is not a randomized trial, meaning treatments are not assigned by the study.","completed","Observational Study of Upright Proton Therapy","This study, called UPRIGHT-PRO, is looking at whether cancer patients can safely receive standard proton therapy while positioned upright. Proton therapy is a type of radiation treatment. The upright treatment system used in this study has been approved by the FDA. The study will observe how patients are treated, the doses they receive, and their outcomes. You may be able to join if you are a child or adult with cancer and your doctor recommends proton therapy. The main goal is to see if upright proton therapy is practical and feasible. The study status is currently unclear, and it plans to include 450 participants.","Feasibility of upright proton therapy will be measured at the end of proton therapy (3 months).",104,"Participants will receive standard-of-care proton therapy at Stanford. The study will observe treatment methods, doses, and outcomes.","Not stated in the trial record.",[],"v2"]