[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503679":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":48,"locations":54,"responsibleParty":74,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":30,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":57,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Columbia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy and Adaptive Radiation Treatment Planning","EXPERIMENTAL","Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg\u002Fmeters squared IV on Day 1) and 5-Fluorouracil (1000mg\u002Fmeters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg\u002Fmeters squared in two divided doses by mouth on days of radiotherapy).",[13,14,15,16],"Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery","Drug: Mitomycin-C","Drug: 5-Fluorouracil","Drug: Capecitabine",[18,25,31,37],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery","Subjects will receive 54 Gy of radiation delivered 5 day a week for 6 weeks, 30 radiation treatments total. Intensity-Modulated photon radiation therapy will be delivered on a Varian Ethos linear accelerator. Daily image-guided radiation therapy (IGRT) is required. All treatments will have artificial-intelligence (AI) daily adaptations of the radiation plan to optimize the radiation dose to the targeted area and minimize radiation dose to the normal surrounding organs such as the bowel.",[9],[24],"Adaptive RT Planning and Delivery",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Mitomycin-C","As part of the subjects' treatment, 10 mg\u002Fmeters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"5-Fluorouracil","As part of the subjects' treatment, 1g\u002Fmeters squared\u002Fday for 4 days of 5-Fluorouracil will be administered by continuous infusion on Days 1-4 (for 96 hours) and Days 29-32 (for 96 hours). 5-Fluorouracil or capecitabine will be administered per the physician's discretion.",[9],[36],"5-FU",{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Capecitabine","As part of the subjects' treatment, 825 mg\u002Fmeters squared per day, divided into 2 daily doses, will be taken on days of radiotherapy. Capecitabine or 5-FU will be administered per the physician's discretion.",[9],[42],"Xeloda",[44],{"name":45,"affiliation":46,"role":47},"Lisa Kachnic, MD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":30,"email":53},"Christina Chesnakov","CONTACT","646-317-4244","cc4047@cumc.columbia.edu",[55],{"facility":56,"status":57,"city":58,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Columbia University Irving Medical Center","RECRUITING","New York","10032","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-74.00597,40.71427,{"lat":66,"lon":65},[69,70,71],{"name":50,"role":51,"phone":30,"phoneExt":30,"email":53},{"name":45,"role":47,"phone":30,"phoneExt":30,"email":30},{"name":72,"role":73,"phone":30,"phoneExt":30,"email":30},"David Horowitz, MD","SUB_INVESTIGATOR",{"type":47,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Lisa A. Kachnic","Chu H. Chang Professor of Radiation Oncology; Chair, Department of Radiation Oncology",[78],{"name":79,"class":80},"Varian Medical Systems","INDUSTRY","100503679","adaptive-radiation-in-anal-cancer-100503679",false,"NCT05838391","Adaptive Radiation in Anal Cancer","Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.\n* American Joint Committee on Cancer (AJCC) 8th edition stage T2 \\> 4 cm, T3-4 or N1.\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).\n* Life expectancy of greater than 12 months.\n* Patients must have normal organ and marrow function as defined below:\n* leukocytes greater than or equal to 3,000\u002Fmicroliter\n* absolute neutrophil count greater than or equal to 1,500\u002Fmicroliter\n* platelets greater than or equal to 100,000\u002Fmicroliter\n* total bilirubin within normal institutional limits\n* Aspartate transaminase (AST)(SGOT)\u002FAlanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal\n* creatinine within normal institutional limits OR creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n* Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.\n* Prior chemotherapy or radiation for anal cancer.\n* Patients who have undergone complete surgical resection.\n* Presence of recurrent\u002Fmetastatic disease.\n* Prior allergic reaction to 5-Fluorouracil or mitomycin C.\n* Artificial organ prosthetics, pacemakers or other implantable devices.\n* Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.\n* Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease.\n* Women who are pregnant or lactating.","ALL","18 Years",{"count":91,"type":92},20,"ESTIMATED","INTERVENTIONAL",[95],"NA","This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.",[98],"Anal Squamous Cell Carcinoma",[100,101,102,103],"Anal cancer","Adaptive radiation","Chemotherapy","Radiotherapy","2026-01-30",{"date":106,"type":107},"2026-02-03","ACTUAL",{"date":109,"type":107},"2023-05-18",{"date":111,"type":92},"2028-12-31",{"name":5,"class":6},1]