[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07647679":3,"trial-entities:NCT07647679":99,"trial-summary:NCT07647679":103},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":68,"locations":71,"central_contacts":90,"overall_officials":94,"references":97,"see_also_links":98},"NCT07647679","Pro00120554","Lattice Radiotherapy for Adults With Large Tumors","Pilot Study of Lattice Radiotherapy in Adults With Large Tumors","NOT_YET_RECRUITING","2030-08","2026-06","2026-07-01","2026-08-01","Duke University","OTHER",false,"The purpose of this study is to ask whether using a specialized radiation therapy technique called Lattice Radiation Therapy (LRT) can shrink large tumors when given with palliative radiation therapy. The primary questions are:\n\n* if LRT is safe and does not worsen existing side effects or cause new side effects\n* if adding LRT to standard radiation therapy can improve tumor shrinkage. Participants will have one additional radiation treatment (LRT) prior to starting palliative radiation and then their progress will be followed for one year.",null,[19,20],"Large Tumor","Palliative Radiotherapy",[22,23,24],"palliative radiation therapy","large tumor","lattice radiation therapy (LRT)","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},25,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"RADIATION","Lattice Radiation Therapy (LRT)","Lattice Radiation Therapy (LRT) is a specialized form of Intensity-Modulated Radiation Therapy (IMRT) designed to provide focused radiation to the deepest part of large tumors.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Incidence of Radiotherapy (RT) treatment-related, non-hematologic Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 90 days","Incidence reported as the number of events divided by the study population.","90 days",[44,47,50],{"measure":45,"description":41,"timeFrame":46},"Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months","12 months",{"measure":48,"timeFrame":49},"Tumor response as measured by change in volume","3 months, 6 months, 12 months",{"measure":51,"timeFrame":49},"Tumor response as measured by change in largest dimension (maximal diameter)","ALL","18 Years",{"inclusion":55,"exclusion":63,"raw_text":67},[56,57,58,59,60,61,62],"Histologically or cytologically confirmed malignancy diagnosis","Radiographic evidence of large extracranial tumor (≥ 4.5 cm)","Patients with primary or metastatic extracranial tumors may be included","Planned to undergo palliative radiation treatment","Life expectancy of at least 3 months","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3","Patient must sign study-specific informed consent",[64,65,66],"Primary lesion with radiosensitive histology (i.e. germ cell tumors, lymphoma, leukemia, and multiple myeloma)","Prior radiation treatment that overlaps with any planned site of protocol radiotherapy that would preclude further palliative RT.","Receiving concurrent cytotoxic cancer therapy regimens or Vascular Endothelial Growth Factor (VEGF) inhibitor that would overlap with LRT administration. Cytotoxic chemotherapy, targeted therapies, small molecule inhibitors, or sVEGF inhibitors prior to radiation treatment or planned after radiation delivery are allowed at the discretion of the treating radiation oncologist.","Inclusion Criteria:\n\n* Histologically or cytologically confirmed malignancy diagnosis\n* Radiographic evidence of large extracranial tumor (≥ 4.5 cm)\n* Patients with primary or metastatic extracranial tumors may be included\n* Planned to undergo palliative radiation treatment\n* Life expectancy of at least 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Patient must sign study-specific informed consent\n\nExclusion Criteria:\n\n* Primary lesion with radiosensitive histology (i.e. germ cell tumors, lymphoma, leukemia, and multiple myeloma)\n* Prior radiation treatment that overlaps with any planned site of protocol radiotherapy that would preclude further palliative RT.\n* Receiving concurrent cytotoxic cancer therapy regimens or Vascular Endothelial Growth Factor (VEGF) inhibitor that would overlap with LRT administration. Cytotoxic chemotherapy, targeted therapies, small molecule inhibitors, or sVEGF inhibitors prior to radiation treatment or planned after radiation delivery are allowed at the discretion of the treating radiation oncologist.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Duke Cancer Center","Durham","North Carolina","27710","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Duke Radiation Oncology Clinical Trials","CONTACT","919-668-3726","RadOnc-Clinical_Trials@dm.duke.edu",{"name":85,"role":86},"Trey Mullikin, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},35.99403,-78.89862,[91],{"name":92,"role":81,"phone":82,"email":93},"Heather Franklin, RN BSN OCN","heather.mccullough@duke.edu",[95],{"name":85,"affiliation":96,"role":86},"Duke Health",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Large Extracranial Tumor",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.","completed","Lattice Radiotherapy for Large Tumors","This study is looking at a special type of radiation therapy called Lattice Radiation Therapy (LRT) for adults with large tumors. LRT is a focused radiation treatment designed to reach the deepest parts of large tumors. Researchers want to see if LRT, when given before standard palliative radiation therapy (treatment to relieve symptoms), is safe and helps shrink tumors. You might be able to join if you have a confirmed cancer diagnosis, a large tumor (at least 4.5 cm), and are planning to receive palliative radiation. The main goal is to check for serious side effects within 90 days. This study is currently unclear on its recruitment status and plans to enroll 25 participants.","Participants will be followed for one year after treatment.",114,"Participants will have one additional radiation treatment (LRT) before starting palliative radiation. Their progress will then be followed for one year.","Not stated in the trial record.",[35],"v2"]