[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-cancer-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-cancer-stage-i":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636301","total-neoadjuvant-therapy-with-additional-consolidation-chemotherapy-followed-by-local-excision-versus-total-neoadjuvant-therapy-followed-by-local-excision-at-stage-i-rectal-cancer-100636301",false,"NCT07563907","Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer","Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial","OPTION","Inclusion Criteria:\n\n* Histologically confirmed rectall adenocarcinoma\n* Low rectal cancer (AV \\\u003C 15cm)\n* cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5\n* Ability to understand and comply with the requirements of the clinical trial\n\nExclusion Criteria:\n\n* Patients who prefer radical rectal resection\n* Prior history of surgery for rectal cancer\n* Recurrent rectal cancer\n* Synchronous metastatic rectal cancer\n* Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis\n* Uncontrolled active infection or other uncontrolled medical condition\n* Known hypersensitivity to chemotherapy\n* Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel","ALL","19 Years","79 Years",{"count":21,"type":22},292,"ESTIMATED","INTERVENTIONAL",[25],"NA","Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial\n\nThe goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.\n\nThe main questions it aims to answer are:\n\n* Does adding consolidation chemotherapy increase the rate of pathologic complete response?\n* What medical problems or side effects do participants have during and after treatment?\n\nResearchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.\n\nParticipants will:\n\n* Receive TNT for stage I rectal cancer\n* Be randomly assigned to one of two treatment groups\n* Undergo local excision after preoperative treatment\n* Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs",[28,29,30,31,32],"Organ Preservation","Rectal Cancer Stage I","Total Neoadjuvant Treatment","Consolidation Therapy","Capecitabine","NOT_YET_RECRUITING","2026-04-26",{"date":36,"type":37},"2026-05-04","ACTUAL",{"date":39,"type":22},"2026-06-01",{"date":41,"type":22},"2035-12-31",{"name":43,"class":44},"Seoul National University Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100589029","phase-2-tumor-local-excision-postoperative-adjuvant-chemoradiotherapy-for-t1-2n0m0-lowultra-low-rectal-cancer-100589029","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","18 Years","75 Years",{"count":56,"type":22},60,[58],"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.",[29],[62,63,64,65],"Adjuvant Chemoradiotherapy","Local excision","Low\u002Fultra-low rectal cancer","Early rectal cancer","RECRUITING","2025-05-28",{"date":69,"type":37},"2025-05-29",{"date":71,"type":37},"2025-05-15",{"date":73,"type":22},"2032-05",{"name":75,"class":44},"Hebei Medical University Fourth Hospital",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100550707","phase-3-preoperative-chemoradiotherapy-and-transanal-endoscopic-microsurgery-versus-ttransanal-endoscopic-microsurgery-in-t1-n0-m0-rectal-cancer-tautem-t1-study-100550707","NCT06450574","Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)","Prospective, Controlled and Randomized Phase III Multicentric Study of the Treatment of T1,N0,M0 Rectal Cancer. Neoadjuvant Therapy and Transanal Endoscopic Surgery vs. Transanal Endoscopic Surgery (TAUTEM-T1 Study)","TAUTEM-T1","Inclusion Criteria:\n\n* Indication by multidisciplinary committee of indication for local excision, according to ESMO and NCCN criteria.\n* Rectal adenocarcinomas in the biopsy, located at a distance from the anal margin less than or equal to 10 cm measured by rigid rectoscopy at the time of ER.\n* Preoperative staging by ER and pelvic MRI of T1,N0. In case of disparity, higher staging will be considered the definitive diagnosis. If it is greater than T1, it will be excluded.\n* Tumors equal to or less than 4 cm in maximum diameter measured by MRI.\n* ASA index equal to or less than III.\n* Absence of distant metastases by abdominal CT and chest X-ray (if inconclusive, Thoracic CT)\n\nExclusion Criteria:\n\n* Preoperative staging by EER or pelvic MRI higher than T1 or N0.\n* Presence of distant metastases. Synchrony with other colorectal adenocarcinomas.\n* Undifferentiated rectal adenocarcinomas or with the presence of poor prognostic factors in the preoperative biopsy (undifferentiated, venous, lymphatic or perineural infiltration, budding) .\n* Patients with intolerance to preoperative chemotherapy or radiotherapy.\n* Do not sign informed consent.",{"count":85,"type":22},106,[87],"PHASE3","Introduction: The standard treatment for rectal adenocarcinoma is total mesorectal excision (TME), a technique involving resection of the rectum, with or without a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. On the other hand, transanal endoscopic surgery (TEM) allows access to tumors up to 20 cm from the anal margin, with much lower postoperative morbidity and without the need for ostomy. For T1, N0, M0 rectal adenocarcinomas without poor prognostic factors, TEM is the technique of choice. However, recent studies have described local recurrences of up to 20%. Our group, TAUTEM, has just completed a phase III clinical trial in T2-T3ab, N0, M0 rectal cancer, comparing preoperative chemoradiotherapy (CRT) and TEM versus TME, with very positive results in terms of postoperative morbidity, quality of life, and a local recurrence rate of 7.4%, not inferior to TME.\n\nThese results encourage our TAUTEM group to launch a similar project at the T1, N0, M0 stage, comparing standard TEM treatment versus QRT and TEM, aiming to improve rectal preservation outcomes and enhance results regarding local recurrence, distant recurrence, and oncologic survival.\n\nMethod: Prospective, controlled, randomized phase III multicenter clinical trial. Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size, staged as T1, N0, M0, will be included. These patients will be randomized into two groups: TEM after CRT and TEM alone. Postoperative morbidity and mortality, CRT side effects, and quality of life will be recorded. The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years. The sample size calculation for the study will be 106 patients.\n\nConclusions: The aim of the study is to improve oncological outcomes in stage T1, N0, M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery (TEM).",[29],[91,92,93,94],"Preoperative chemoradiotherapy","Transanal endoscopic microsurgery","Rectal Cancer","T1-N0-M0 Rectal cancer","2024-06-07",{"date":97,"type":37},"2024-06-10",{"date":99,"type":22},"2024-10",{"date":101,"type":22},"2027-10",{"name":103,"class":44},"Corporacion Parc Tauli"]