Evidence map›Paper›PMID 42026347›Full record

Trial reportInternational journal of colorectal disease2026

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).

Xavier Serra-Aracil, Anna Nonell, Cristina Gener-Jorge, Carles Pericay, Thomas Golda, Esther Kreisler, Eloy Espin-Basany, Anna Pallisera, Jesus Badia-Closa, Beatriz Espina and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of colorectal disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06450574 (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), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT06450574 phase3not yet recruitingnot on this map

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)

TypeinterventionalSponsorCorporacion Parc TauliRan2024 to 2027Enrolled106ConditionsRectal Cancer Stage IArmsCapecitabine (Xeloda), 50.4 Gy, Transanal Endoscopic Microsurgery (TEM), Transanal Endoscopic Microsurgery
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Xavier Serra-AracilDepartment of Surgery, Universitat Autònoma de Barcelona, Coloproctology Unit, Parc Tauli University Hospital, Institut d'investigació I Innovació Parc Tauli I3PT-CERCA, Sabadell (Barcelona), Spain. javier.serra@uab.cat.ORCID http://orcid.org/0000-0003-0291-1900
Anna NonellDepartment of Surgery, Universitat Autònoma de Barcelona, Coloproctology Unit, Parc Tauli University Hospital, Institut d'investigació I Innovació Parc Tauli I3PT-CERCA, Sabadell (Barcelona), Spain.
Cristina Gener-JorgeDepartment of Pathology, Universitat Autònoma de Barcelona, Parc Tauli University Hospital, Institut d'investigació I Innovació Parc Tauli I3PT-CERCA, Sabadell (Barcelona), Spain.
Carles PericayMedical Oncology Department, Mutua de Terrassa University Hospital, Terrassa (Barcelona), Spain.
Thomas GoldaColorectal Unit, General and Digestive Surgery Department, Bellvitge University Hospital, Barcelona, Spain.
Esther KreislerColorectal Unit, General and Digestive Surgery Department, Bellvitge University Hospital, Barcelona, Spain.
Eloy Espin-BasanyColorectal Unit, General and Digestive Surgery Department, Vall d'Hebron University Hospital, Departamento de Cirugía, Universitat Autònoma de Barcelona, Barcelona, Spain.
Anna PalliseraDepartment of Surgery, Universitat Autònoma de Barcelona, Coloproctology Unit, Parc Tauli University Hospital, Institut d'investigació I Innovació Parc Tauli I3PT-CERCA, Sabadell (Barcelona), Spain.
Jesus Badia-ClosaColorectal Unit, General and Digestive Surgery Department, Hospital de San Juan Despí Moisès Broggi, Barcelona, Spain.
Beatriz EspinaColorectal Unit, General and Digestive Surgery Department, Santa Creu I Sant Pau University Hospital, Barcelona, Spain.
Nerea Borda-ArrizabalagaGeneral and Digestive Surgery Department, Donostia University Hospital, Donostia, Gipuzkoa, Spain.
Angel ReinaColorectal Unit, Unidad de Gestión Clínica Cirugía y Area de Gestión Norte de Almería, Complejo Hospitalario Torrecárdenas, Almería, Spain.
Hector Guadalajara-LabajoColorectal Unit, General and Digestive Surgery Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Ana OteroGeneral and Digestive Surgery Department, Hospital Clinic University Hospital, Barcelona, Spain.
Salvadora DelgadoColorectal Unit, General and Digestive Surgery Department, Mutua de Terrassa University Hospital, Terrassa (Barcelona), Spain.
Miquel KraftColorectal Unit, General and Digestive Surgery Department, Vall d'Hebron University Hospital, Departamento de Cirugía, Universitat Autònoma de Barcelona, Barcelona, Spain.
Rosa QuerolDepartment of Medical Oncology, Universitat Autònoma de Barcelona, Coloproctology Unit, Parc Tauli University Hospital, Institut d'investigació I Innovació Parc Tauli I3PT-CERCA, Sabadell, Spain.
Blas FlorColorectal Unit, General and Digestive Surgery Department, La Fe University Hospital, Valencia, Spain.
Gianluca PellinoColorectal Unit, General and Digestive Surgery Department, Vall d'Hebron University Hospital, Departamento de Cirugía, Universitat Autònoma de Barcelona, Barcelona, Spain.
Sebastiano BiondoColorectal Unit, General and Digestive Surgery Department, Bellvitge University Hospital, Barcelona, Spain.
Aleidis Caro-TarragoColorectal Unit, General and Digestive Surgery Department, Joan XXIII University Hospital, Tarragona, Spain.
TAUTEM-T1 collaborative group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFor 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.

methodsMulticenter, 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.

resultsThis manuscript describes the rationale and design of the TAUTEM-T1 randomized trial.

conclusionTAUTEM-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 registrationClinicalTrials.gov, NCT06450574.

Indexed as

ChemoradiotherapyRectal NeoplasmsTransanal Endoscopic SurgeryHumansNeoplasm Recurrence, LocalNeoplasm StagingQuality of LifeLocal excision and rectal cancerNeoadjuvant treatment and rectal cancerRectal cancerTotal mesorectal excision (TME)Transanal endoscopic microsurgery (TEM)

Identifiers

PMID42026347
PMCPMC13236827

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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.