Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer
NCT ID: NCT01308190
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2010-08-31
2021-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy+TEM
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
Capecitabine (Xeloda)
Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
50.4 Gy
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
Transanal Endoscopic Microsurgery
6-8 weeks after Chemoradiotherapy
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis
Interventions
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Capecitabine (Xeloda)
Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
50.4 Gy
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
Transanal Endoscopic Microsurgery
6-8 weeks after Chemoradiotherapy
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. ASA score III or less.
5. Absence of distance metastasis as shown on abdominal CT.
Exclusion Criteria
2. Presence of distance metastasis.
3. Synchrony with other colorectal adenocarcinomas.
4. Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
5. Patients with intolerance of preoperative chemotherapy or radiotherapy.
6. Refusal to sign informed consent to enter the study.
18 Years
ALL
No
Sponsors
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Fundación Olga Torres
UNKNOWN
Corporacion Parc Tauli
OTHER
Responsible Party
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Xavier Serra-Aracil
Medical Doctor
Locations
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Corporació Parc Taulí
Sabadell, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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TAU-TEM-2009-01
Identifier Type: -
Identifier Source: org_study_id