[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652746":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":32,"collaborators":20,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":20,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":20},{"fullName":5,"class":6},"University of Vermont Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Hypofractionated Chemoradiation","EXPERIMENTAL","Participants receive mildly hypofractionated radiation therapy delivered in 23 fractions using a simultaneous integrated boost approach with concurrent standard-of-care mitomycin C and capecitabine chemotherapy.",[13],"Radiation: Hypofractionated Radiation Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Hypofractionated Radiation Therapy","Participants receive mildly hypofractionated radiation therapy delivered in 23 fractions using a simultaneous integrated boost approach, given concurrently with standard-of-care mitomycin C and capecitabine chemotherapy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Christopher L Anker, MD","University of Vermont Cancer Center","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Chris Anker, MD","CONTACT","1 (802) 656-2021","chris.anker@uvmhealth.org",{"type":25,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Christopher Anker","Radiation Oncologist. Professor, Radiation-Oncology","100652746","phase-2-shortening-radiation-course-duration-using-simultaneous-integrated-boost-with-lower-intensity-elective-nodal-dosing-and-concurrent-chemotherapy-for-high-risk-anal-squamous-cell-carcinoma-100652746",false,"NCT07775209","Shortening Radiation Course Duration Using Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing and Concurrent Chemotherapy for High-Risk Anal Squamous Cell Carcinoma","Shortening Radiation Course Duration Via Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing While Giving Concurrent Chemotherapy for High-risk Anal Squamous Cell Carcinoma - a Phase 2 Study","SSIBLING","Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically or cytologically confirmed non-metastatic anal squamous cell carcinoma meeting one of the following criteria:\n\nT2 tumor measuring ≥4 cm T3 or T4 disease Any node-positive disease\n\n* Patients with HPV-associated (p16-positive) perianal cancer are eligible if the tumor extends to the anal verge\n* Karnofsky Performance Status \\>60\n* Creatinine clearance \\>30 mL\u002Fmin\n* Considered by the investigator to be appropriate candidates for concurrent capecitabine and mitomycin C chemotherapy\n* Ability to understand and willingness to provide informed consent\n* For participants of childbearing potential: negative pregnancy test or documented absence of pregnancy per institutional standard within 14 days prior to registration\n* Participants of reproductive potential must agree to use adequate contraception during study treatment and for 90 days after completion of therapy\n\nExclusion Criteria:\n\n* Prior pelvic radiation therapy\n* Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine\n* Prior or concurrent malignancy that, in the opinion of the investigator, could interfere with assessment of safety or efficacy\n* Current receipt of another investigational agent for treatment of anal squamous cell carcinoma","ALL","18 Years",{"count":46,"type":47},24,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","This phase 2 single-arm study will evaluate whether a shortened course of mildly hypofractionated radiation therapy given with standard concurrent chemotherapy (mitomycin C and capecitabine) can provide acceptable tumor control in patients with high-risk non-metastatic anal squamous cell carcinoma. Standard chemoradiation for anal cancer typically requires approximately 5.5 to 6 weeks of daily radiation, which can create substantial logistical burden for patients and caregivers, particularly those in rural settings.\n\nThe investigational approach uses a 23-fraction radiation regimen designed to shorten treatment duration while maintaining biologically equivalent tumor-directed dosing compared with standard treatment. The primary question is whether this shorter chemoradiation regimen can achieve an acceptable 6-month complete clinical response rate while maintaining manageable toxicity.",[53],"Anal Cancer",[55,17,56],"anal squamous cell carcinoma","Circulating Tumor DNA","NOT_YET_RECRUITING","2026-08-17",{"date":60,"type":61},"2026-08-20","ACTUAL",{"date":63,"type":47},"2029-05",{"date":65,"type":47},"2040-04",{"name":5,"class":6}]