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).
Abstract
[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.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 기법 | endoscopic
|
내시경 | dict | 3 |
🔗 함께 등장하는 도메인
이 논문이 속한 카테고리와 같은 논문에서 자주 함께 다뤄지는 카테고리들
관련 논문
- Endoscopic Assistance in Surgery for Insular Lesions: Anatomic Study and Clinical Application.
- Endoscopic disconnection of hypothalamic hamartoma: an already outdated story?
- Single-port Non-liposuction Endoscopic Axillary Lymph Node Dissection in Breast Cancer Surgery.
- Clinical Efficacy Analysis of Functional Rhinoplasty Assisted by Nasal Endoscopy.
- Transaxillary Breast Augmentation: Selection of the Incision, Pocket, and Surgical Technique.