Trial reportInternational journal of colorectal disease2018
Non-inferiority multicenter prospective randomized controlled study of rectal cancer T
Trial report in International journal of colorectal disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized Clinical Trial for no Inferiority With Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery (TEM) Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer
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)
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Systematic review of functional outcomes and quality of life after transanal endoscopic microsurgery and transanal minimally invasive surgery: a word of caution.International journal of colorectal disease · 2020Pooled it
- Executive Summary of the American Radium Society Appropriate Use Criteria for Local Excision in Rectal Cancer.International journal of radiation oncology, biology, physics · 2019Guideline
- Treatment Options for Distal Rectal Cancer in the Era of Organ Preservation.Current treatment options in oncology · 2024Review
- The Role of Local Excision after Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Different Perspective.Clinics in colon and rectal surgery · 2023Article
- Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy.The Cochrane database of systematic reviews · 2023Review
- Review
- SEOM-GEMCAD-TTD clinical guidelines for localized rectal cancer (2021).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022Article
- Local excision and chemoradiation for clinical node-negative anal adenocarcinoma.Surgical oncology · 2021Article
- Watch and wait approach in rectal cancer: Current controversies and future directions.World journal of gastroenterology · 2020Review
- Local excision following chemoradiotherapy in T2-T3 rectal cancer: current status and critical appraisal.Updates in surgery · 2020Review
- Transanal endoscopic microsurgery for rectal lesions in a specialist regional early rectal cancer centre: the Mersey experience.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2019Article
- Transanal total mesorectal excision for low rectal cancer: a case-matched study comparing TaTME versus standard laparoscopic TME.Cancer management and research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe standard treatment of rectal adenocarcinoma is total mesorectal excision (TME), in many cases requires a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal verge, achieves minimal postoperative morbidity and mortality rates, and does not require an ostomy. The treatment of T2, N0, and M0 cancers remains controversial. Preoperative chemoradiotherapy (CRT) in association with TEM reduces local recurrence and increases survival. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with TEM compared with TME.
methodsProspective, multicenter, randomized controlled non-inferiority trial includes patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2 or T3-superficial N0-M0. Patients will be randomized to two areas: CRT plus TEM or radical surgery (TME). Postoperative morbidity and mortality will be recorded and patients will complete the quality of life questionnaires before the start of treatment, after CRT in the CRT/TEM arm, and 6 months after surgery in both arms. The estimated sample size for the study is 173 patients. Patients will attend follow-up controls for local and systemic relapse.
conclusionsThis study aims to demonstrate the preservation of the rectum after preoperative CRT and TEM in rectal cancer stages T2-3s, N0, M0 and to determine the ability of this strategy to avoid the need for radical surgery (TME).
trial registrationClinicalTrials.gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.