[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592815":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Vermont Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Moderate-Risk Cohort","EXPERIMENTAL","Patients meeting moderate-risk criteria will not receive adjuvant radiation therapy but will instead be monitored through regular clinical exams and imaging. This arm evaluates whether active surveillance is a safe alternative to radiation in this population by tracking recurrence rates and overall survival.",[13],"Other: Active Surveillance",{"label":15,"type":10,"description":16,"interventionNames":17},"High-Risk Cohort","Patients classified as high risk will undergo SCRT, consisting of five fractions of radiation therapy over a two-week period. This approach aims to provide effective local control while minimizing treatment burden compared to conventional long-course radiation therapy (typically 30+ fractions over six weeks). The study will assess the efficacy, safety, and long-term outcomes of SCRT, including recurrence rates, toxicity profiles, and patient-reported quality of life.",[18,13],"Radiation: Short course radiation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Short course radiation","The radiation arm in this study involves Short Course Radiation Therapy (SCRT), which consists of 5 fractions delivered twice a week (either Monday\u002FThursday or Tuesday\u002FFriday).",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Active Surveillance","The Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT\u002FMRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s",[15,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Christopher Anker, MD","CONTACT","(802) 656-2021","chris.anker@uvmhealth.org",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Burlington","Vermont","05401","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-73.21207,44.47588,{"lat":48,"lon":47},[51,53,56],{"name":32,"role":33,"phone":52,"phoneExt":25,"email":35},"7739804380",{"name":54,"role":33,"phone":34,"phoneExt":25,"email":55},"Ben Briggs, QA Officer","benjamin.briggs@uvmhealth.org",{"name":32,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Christopher Anker","Radiation Oncologist. Professor, Radiation-Oncology","100592815","phase-2-mohs-surgery-and-short-course-radiation-therapy-with-structured-follow-up-for-head--neck-squamous-cell-skin-cancer-100592815",false,"NCT06998342","MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer","MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)","MOHSAHRTSS","Inclusion Criteria:\n\n* Pathologically confirmed cutaneous squamous cell carcinoma of the head \\& neck region, defined as extending from vertex of head to supraclavicular region.\n* Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration\n* Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup:\n\n  * Clinical exam within 60 days prior to registration\n  * CT head \\& neck\u002Fsoft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.\n  * Bilateral neck ultrasound within 60 days prior to registration\n* Risk Factors fitting either the High-Risk or Moderate-Risk Categories:\n\n  * Risk Factor Definitions\n\nMajor Risk Factors: Microscopic Extensive PNI (defined as PNI for \\>3 nerves with all involved nerves either \\>0.1 mm in size and\u002For deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \\>6 cm, or Recurrent disease status post prior Mohs\n\nModerate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \\>0.1 mm in size)\n\nBWH Risk factors: \\>2 cm, poor differentiation, deep invasion, PNI (\\>0.1 mm in size)\n\n• BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors\n\nHigh-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3\n\nModerate-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.\n\nExclusion Criteria:\n\n* Patients receiving any other investigational agents.\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\nSerious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.\n\nPrior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n\nPrior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n\nActively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.","ALL","18 Years",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery.\n\nThe main questions it aims to answer are:\n\nDoes short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation?\n\nResearchers will compare:\n\nShort-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness.\n\nActive surveillance for moderate-risk patients to expected recurrence rates to assess safety.\n\nParticipants will:\n\nHigh-Risk Group (SCRT): Receive short-course radiation therapy and attend follow-up visits.\n\nModerate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence.\n\nOptionally provide blood samples for future biomarker research.",[79],"Cutaneous Squamous Cell Carcinoma (CSCC)",[81,82,83,84,85,86,87],"Cutaneous Squamous Cell Carcinoma","Head and Neck Cancer","Neoadjuvant Therapy","Immunotherapy","Surgical Oncology","Clinical Trial","Radiation","2026-05-20",{"date":90,"type":91},"2026-05-26","ACTUAL",{"date":93,"type":91},"2025-06-04",{"date":95,"type":73},"2031-05",{"name":5,"class":6},1]