[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630083":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":41,"collaborators":43,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":26,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":26},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesorectal chemoradiotherapy","EXPERIMENTAL","Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg\u002Fm² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured \"watch and wait\" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care.",[13],"Combination Product: Capecitabine + Radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Surgery (Total Mesorectal Excision)","ACTIVE_COMPARATOR","Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm.",[19],"Procedure: Total Mesorectal Excision (TME)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Capecitabine + Radiotherapy","Capecitabine is administered orally at a dose of 825 mg\u002Fm² twice daily on radiotherapy treatment days (5 days per week) during the 5-week course of mesorectal radiotherapy. External beam radiotherapy is delivered to the primary tumor and surrounding mesorectum at a total dose of 50 Gy in 25 fractions (2 Gy per fraction), administered once daily, 5 days per week, over approximately 5 weeks, according to protocol-defined target volumes.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Total Mesorectal Excision (TME)","Total mesorectal excision (TME) is performed according to standard surgical practice for rectal cancer. The surgical approach (open, laparoscopic, or robotic) is determined by the treating surgeon in accordance with local guidelines.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Eva Angenete, MD, PhD","CONTACT","+46-31-342-10-00","eva.angenete@gu.se",{"name":39,"role":35,"phone":26,"phoneExt":26,"email":40},"Jennifer Park, MD, PhD","jennifer.park@gu.se",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[44,47],{"name":45,"class":46},"Skane University Hospital","OTHER",{"name":48,"class":46},"Stockholm South General Hospital","100630083","phase-4-next-generation-star-trec-ng-st---organ-preservation-in-early-rectal-cancer-100630083",false,"NCT07483060","Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer","Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer","NG-ST","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Biopsy-proven rectal adenocarcinoma\n* Tumor located \\\u003C12 cm from the anal verge\n* MRI-staged T1-T3b tumor\n* N0 or NX (no radiologic evidence of nodal metastases)\n* M0 or MX (no radiological evidence of distant metastases)\n* ECOG performance status 0-1\n* Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options\n\nExclusion Criteria:\n\n* MRI-defined N1 or higher nodal disease\n* Distant metastases (M1)\n* MRI extramural vascular invasion (mriEMVI)\n* Threatened mesorectal fascia (≤1 mm on MRI)\n* Maximum tumor diameter \\> 40 mm\n* MRI defined mucinous tumor\n* No residual luminal tumor following prior endoscopic resection\n* Recurrent rectal cancer\n* Prior pelvic radiotherapy\n* Uncontrolled significant cardiorespiratory comorbidity\n* Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency\n* Known Gilbert's syndrome\n* Pregnancy or breastfeeding\n* Concomitant medication contraindicated with capecitabine that cannot be safely discontinued\n* Age \\\u003C18 years","ALL","18 Years",{"count":60,"type":61},90,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.",[67],"Rectal Cancer",[69,70,71,72,73,74,75],"Early rectal cancer","organ preservation","watch and wait","chemoradiotherapy","clinical complete response","quality of life","low anterior resection syndrom","NOT_YET_RECRUITING","2026-03-16",{"date":79,"type":80},"2026-03-19","ACTUAL",{"date":82,"type":61},"2026-03-12",{"date":84,"type":61},"2031-12",{"name":5,"class":6}]