[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589029":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":22,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":22,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":22,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":42,"whyStopped":22,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Hebei Medical University Fourth Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy","EXPERIMENTAL","All enrolled patients will first undergo local tumor resection. Adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging:\n\nFor pT1N0M0 patients without high-risk features:\n\nActive surveillance OR Radiotherapy alone (Prescription: Pelvic field irradiation 45Gy in 25 fractions)\n\nFor pT2N0M0 or pT1N0M0 patients with adverse prognostic factors:\n\nAdjuvant chemoradiotherapy (Prescription:Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 5.4Gy in 3 fractions；Concurrent chemotherapy: Oral capecitabine 825mg\u002Fm² twice daily)；For patients with positive margins after local excision: Re-excision followed by adjuvant chemoradiotherapy OR Dose-escalated chemoradiotherapy (Prescription: Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 14.4Gy in 8 fractions)；\n\nFor patients with staging \\> pT2N0M0:\n\nTotal mesorectal excision (TME) Following treatment completion, patients will enter clinical follow-up surveillance.",[13,14,15],"Procedure: Local Tumor Resection","Radiation: Radiotherapy","Drug: Chemotherapy",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Local Tumor Resection","All enrolled patients will first undergo local tumor resection.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"RADIATION","Radiotherapy","Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions.\n\nFor patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy\u002F25 fractions + tumor bed local boost 14.4Gy\u002F8 fractions) can be given.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"DRUG","Chemotherapy","Concurrent oral capecitabine 825 mg\u002Fm² twice daily with radiotherapy",[9],[34],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"chaoxi Zhou","CONTACT","15931121563","zhouchaoxi81@163.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":22,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":22},"The Fourth Hospital of Hebei Medical University","RECRUITING","Shijiazhuang","Hebei","China","CN",{"type":48,"coordinates":49},"Point",[50,51],114.47861,38.04139,{"lat":51,"lon":50},{"type":54,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100589029","phase-2-tumor-local-excision-postoperative-adjuvant-chemoradiotherapy-for-t1-2n0m0-lowultra-low-rectal-cancer-100589029",false,"NCT06949098","Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low\u002FUltra-Low Rectal Cancer","An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low\u002FUltra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender\n2. ECOG performance status 0-1\n3. Biopsy-proven rectal adenocarcinoma\n4. Distal margin of primary tumor ≤8 cm from anal verge\n5. Clinical stage I (cT1-2N0M0)\n6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)\n7. The surgeon determined a local resection was feasible\n8. No contraindications to chemoradiotherapy\n\nExclusion Criteria:\n\n1. Failure to meet the above inclusion criteria\n2. Patients refusing to sign informed consent\n3. Impaired cognitive function or psychiatric disorders\n4. Patients deemed ineligible by investigators","ALL","18 Years","75 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low\u002Fultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low\u002Fultra-low rectal cancer.",[73],"Rectal Cancer Stage I",[75,76,77,78],"Adjuvant Chemoradiotherapy","Local excision","Low\u002Fultra-low rectal cancer","Early rectal cancer","2025-05-28",{"date":81,"type":82},"2025-05-29","ACTUAL",{"date":84,"type":82},"2025-05-15",{"date":86,"type":67},"2032-05",{"name":5,"class":6},1]