Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

NCT01308190 | Completed Phase 3

• 1 other identifier: TAU-TEM-2009-01
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas consider TEM to be the technique of choice. However the treatment of T2 rectal cancers remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant reduction in local recurrence and an increase in survival. Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3 N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve effective results in terms of local recurrence similar to radical surgery (TME). OBJECTIVES: Primary: To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME). Secondary: To analyse the 3-year survival results in patients treated with CT/RT. Methodology: Multicenter clinical trial in a calculated sample of 173 patients.

Conditions

Rectal Cancer

Keywords

Preoperative chemoradiotherapy; Transanal endoscopic microsurgery; Rectal Cancer; T2-T3s-N0

Outcome Measures

Primary Outcomes (1)

• Local recurrence

  To analyse the results for local recurrence after 2 years in patients treated with preoperative chemoradiotherapy and TEO, with patients treated with conventional radical surgery (TME).

  2 years

Study Arms (2)

Chemoradiotherapy+TEM

ACTIVE COMPARATOR

Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 weeks, transanal endoscopic microsurgery (TEM)is done

Drug: Capecitabine (Xeloda); Radiation: 50.4 Gy; Procedure: Transanal Endoscopic Microsurgery

Total Mesorectal Excision

OTHER

Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer

Procedure: Total Mesorectal Excision

Interventions

Capecitabine (Xeloda) DRUG

Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy

Chemoradiotherapy+TEM

50.4 Gy RADIATION

Radiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area

Chemoradiotherapy+TEM

Transanal Endoscopic Microsurgery PROCEDURE

6-8 weeks after Chemoradiotherapy

Chemoradiotherapy+TEM

Total Mesorectal Excision PROCEDURE

Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis

Total Mesorectal Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
• Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N0. In case of disparity, the higher staging is considered as the definitive diagnosis.
• Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
• ASA score III or less.
• Absence of distance metastasis as shown on abdominal CT.

You may not qualify if:

• Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
• Presence of distance metastasis.
• Synchrony with other colorectal adenocarcinomas.
• Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
• Patients with intolerance of preoperative chemotherapy or radiotherapy.
• Refusal to sign informed consent to enter the study.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Fundación Olga Torres: collaborator

Study Sites (1)

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (6)

• Serra Aracil X, Bombardo Junca J, Mora Lopez L, Alcantara Moral M, Ayguavives Garnica I, Darnell Marti A, Casalots Casado A, Pericay Pijaume C, Campo Fernandez de Los Rios R, Navarro Soto S. [Site of local surgery in adenocarcinoma of the rectum T2N0M0]. Cir Esp. 2009 Feb;85(2):103-9. doi: 10.1016/j.ciresp.2008.09.007. Epub 2009 Feb 5. Spanish.

  PMID: 19231466 BACKGROUND

• Serra-Aracil X, Vallverdu H, Bombardo-Junca J, Pericay-Pijaume C, Urgelles-Bosch J, Navarro-Soto S. Long-term follow-up of local rectal cancer surgery by transanal endoscopic microsurgery. World J Surg. 2008 Jun;32(6):1162-7. doi: 10.1007/s00268-008-9512-1.

  PMID: 18338206 BACKGROUND

• Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Espin-Bassany E, Caro-Tarrago A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo H, Otero A, Biondo S; TAUTEM Collaborative Group. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398.

  PMID: 40434784 DERIVED

• Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.

  PMID: 37310167 DERIVED

• Serra-Aracil X, Pericay C, Badia-Closa J, Golda T, Biondo S, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Vallribera F, Caro A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo HG, Mora-Lopez L. Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study). Ann Oncol. 2023 Jan;34(1):78-90. doi: 10.1016/j.annonc.2022.09.160. Epub 2022 Oct 8.

  PMID: 36220461 DERIVED

• Serra-Aracil X, Pericay C, Golda T, Mora L, Targarona E, Delgado S, Reina A, Vallribera F, Enriquez-Navascues JM, Serra-Pla S, Garcia-Pacheco JC; TAU-TEM study group. Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME). Int J Colorectal Dis. 2018 Feb;33(2):241-249. doi: 10.1007/s00384-017-2942-1. Epub 2017 Dec 12.

  PMID: 29234923 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Transanal Endoscopic Microsurgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Transanal Endoscopic Surgery; Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Microsurgery; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

ES (1)