International journal of colorectal disease · 2026
Chemoradiotherapy and transanal endoscopic surgery versus transanal endoscopic surgery alone in T1N0M0 rectal cancer: a multicenter, randomized, controlled, phase III clinical trial (TAUTEM-T1 study).
СтатьяКлиническое исследование III фазыМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Serra-Aracil Xavier, Nonell Anna, Gener-Jorge Cristina, Pericay Carles, Golda Thomas, Kreisler Esther, Espin-Basany Eloy, Pallisera Anna, Badia-Closa Jesus, Espina Beatriz, Borda-Arrizabalaga Nerea, Reina Angel, Guadalajara-Labajo Hector, Otero Ana, Delgado Salvadora, Kraft Miquel, Querol Rosa, Flor Blas, Pellino Gianluca, Biondo Sebastiano, Caro-Tarrago Aleidis, TAUTEM-T1 collaborative group
Аннотация
PURPOSE: For clinical (c) T1N0M0 rectal adenocarcinoma without adverse pathological features, local excision by transanal endoscopic surgery (TEM) is standard; however, contemporary series still report local recurrence (LR) rates of 15-20%. Preoperative unfavorable histopathologic features cannot reliably identify high-risk pT1 disease, and both completion total mesorectal excision (TME) and salvage TME for LR carry relevant morbidity and functional impairment. Building on our prior phase III trial in T2-T3abN0M0 (TAUTEM study), showing that preoperative chemoradiotherapy (CRT) followed by TEM achieved a 7.4% LR with improved postoperative outcomes, we hypothesize that CRT + TEM will increase rectal preservation in cT1N0M0 without compromising oncologic safety or quality of life. The TAUTEM-T1 trial tests this hypothesis.
METHODS: Multicenter, prospective, randomized, controlled, phase III superiority trial. Adults with biopsy-proven rectal low or moderate grade adenocarcinoma ≤ 4 cm, located < 10 cm from the anal verge, staged as cT1N0M0, are randomized (1:1) to: CRT (long-course radiotherapy with concurrent capecitabine) followed by TEM at week 10, or TEM alone. The primary endpoint is rectal preservation at 3 years. Secondary endpoints include postoperative morbidity/mortality, CRT-related adverse events, quality of life and anorectal function, and long-term oncologic outcomes (local/distant recurrence, overall and disease-free survival). Planned sample size: 106 patients.
RESULTS: This manuscript describes the rationale and design of the TAUTEM-T1 randomized trial.
CONCLUSION: TAUTEM-T1 will assess whether preoperative CRT followed by TEM increases rectal preservation in cT1N0M0 rectal cancer without compromising oncologic safety, quality of life, or bowel function.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT06450574.
METHODS: Multicenter, prospective, randomized, controlled, phase III superiority trial. Adults with biopsy-proven rectal low or moderate grade adenocarcinoma ≤ 4 cm, located < 10 cm from the anal verge, staged as cT1N0M0, are randomized (1:1) to: CRT (long-course radiotherapy with concurrent capecitabine) followed by TEM at week 10, or TEM alone. The primary endpoint is rectal preservation at 3 years. Secondary endpoints include postoperative morbidity/mortality, CRT-related adverse events, quality of life and anorectal function, and long-term oncologic outcomes (local/distant recurrence, overall and disease-free survival). Planned sample size: 106 patients.
RESULTS: This manuscript describes the rationale and design of the TAUTEM-T1 randomized trial.
CONCLUSION: TAUTEM-T1 will assess whether preoperative CRT followed by TEM increases rectal preservation in cT1N0M0 rectal cancer without compromising oncologic safety, quality of life, or bowel function.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT06450574.