TAU-TEM
Needs reviewProspective 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
Phase 3N = 173NCT01308190
- Population
- Patients with rectal adenocarcinoma located lower than 10 cm from the anal verge, staged T2-T3ab, N0, M0, with a tumour of up to 4 cm in diameter and American Society of Anesthesiologists stage III or less
- Design
- Prospective, multicentre (17 Spanish hospitals), open-label, randomised noninferiority phase 3 trial of preoperative chemoradiotherapy followed by transanal endoscopic microsurgery (CRT-TEM) versus total mesorectal excision (TME) in patients with T2-T3ab N0 M0 rectal adenocarcinoma. From July 2010 to October 2021, 173 patients were included (86 and 87); 11 were excluded after randomisation and the modified intention-to-treat analysis included 81 patients per group. The 2025 report states the main outcome as locoregional recurrence (LR), tested for noninferiority with a one-sided margin of 10%; the sample size assumed a nonrecurrence rate of 95% in each arm, a one-sided significance level of 2.5%, 80% power and a possible loss of 15%. Its stated objective is recurrence after 2 years of follow-up, but the results are reported as a 5-year modified intention-to-treat analysis (median follow-up 63 months, IQR 40 to 86, in the full text). Distant recurrence, overall survival and disease-free survival were secondary outcomes. The 2023 report covers morbidity and pathological outcomes.
- Primary endpoint
- Locoregional recurrence of rectal cancer
- Arms
- Chemoradiotherapy and transanal endoscopic microsurgery (experimental, n = 86): Preoperative chemoradiotherapy followed by transanal endoscopic microsurgery
- Total mesorectal excision (control, n = 87): Total mesorectal excision
- People
- Serra-Aracil X, senior author Mora-Lopez L
Δ Locoregional recurrence of rectal cancer+1.2 pointsΔ Distant recurrence of rectal cancer−5 pointsΔ OS−2.5 pointsΔ DFS0 pointsΔ Postoperative morbidity−29.9 points
Show the numbers
| Endpoint | Analysis | Chemoradiotherapy and transanal endoscopic microsurgery | Total mesorectal excision | Effect |
|---|---|---|---|---|
| Locoregional recurrence of rectal cancer5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)Main outcome of TAU-TEM: locoregional recurrence in the 5-year modified intention-to-treat analysis, given as the number of patients with recurrence among 81 per group. The abstract's objective is recurrence after 2 years of follow-up with a one-sided noninferiority margin of 10%. | primarySerra-Aracil 2025 | 7.4% | 6.2% | 6 of 81 patients with chemoradiotherapy and local excision and 5 of 81 with total mesorectal excision. The abstract and the full text print the difference as -1.23% (it equals the TME percentage minus the CRT-TEM percentage) with an interval of '6.51% to -8.98%', upper bound first. The Results compare the lower bound, -8.98, with the 10% margin and conclude noninferiority; the Results text calls the interval one-sided 97.5%, while the footnote of Table 2 calls it one-sided at the 95% level. Full text only: P = .76 is printed beside the difference; in the per-protocol analysis CRT-TEM had 5 of 66 (7.6%); median follow-up was 63 months (IQR 40 to 86) for the analysed patients. The abstract does not say how the 5-year proportions were estimated. |
| Distant recurrence of rectal cancer5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)Distant recurrence in the 5-year modified intention-to-treat analysis (secondary outcome), given as the number of patients with recurrence among 81 per group. | long term-updateSerra-Aracil 2025 | 12.3% | 17.3% | 10 of 81 patients with chemoradiotherapy and local excision and 14 of 81 with total mesorectal excision. The abstract prints the difference as 4.94% (TME minus CRT-TEM) with an interval of '15.85% to -5.98%', upper bound first, and states no P value. The full text states that the study was not powered for secondary outcomes. |
| OS5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)5-year overall survival (secondary outcome), given as the number of patients alive among 81 per group. | long term-updateSerra-Aracil 2025 | 82.7% | 85.2% | 67 of 81 patients with chemoradiotherapy and local excision and 69 of 81 with total mesorectal excision. The abstract prints the difference as 2.47% with an interval of '0.38%-1.78%', which does not contain the difference and matches the interval of the overall survival hazard ratio in the full text; the full text (Results and Table 2) prints the interval for the difference as '13.77% to -8.83%'. The abstract does not say how the 5-year percentages were estimated. |
| DFS5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)5-year disease-free survival (secondary outcome), given as the number of patients disease-free among 81 per group. | long term-updateSerra-Aracil 2025 | 88.9% | 88.9% | 72 of 81 patients in each group. The abstract prints an interval of '9.68 to -9.68' for the difference between the groups and states no P value. In the full text, Table 2 gives 72 of 81, but one sentence of the Results gives 73 of 81. |
| Postoperative morbidityModified intention-to-treat analysis: 81 patients in each group; the abstract's morbidity denominators are 82 (CRT-TEM) and 81 (TME)Postoperative morbidity (surgical complications graded by the Clavien-Dindo and Comprehensive Complication Index classifications), short-term report | interimSerra-Aracil 2023 | 20.7% | 50.6% | P<0.00117 of 82 patients versus 41 of 81, as printed in the abstract; the denominator of 82 does not match the 81 patients stated for the analysis. The abstract also prints a 95% confidence interval of '42.9% to 16.7%', which is not stored. One patient died in each group. The 2025 JAMA Surgery report repeats the figure as 17 of 82 (20.7%) in its text and as 17/81 (20.7%) in its Table 1; 17 of 81 would be 21.0%, so the published percentage is kept. This is a short-term report; the trial's cancer outcomes (2025) are recorded as separate results. |
| Organ preservation rate81 patients in the CRT-TEM group who received the allocated treatmentPatients who underwent organ preservation among those who received the allocated CRT-TEM treatment (short-term report) | interimSerra-Aracil 2023 | 82.7% | — | 67 of 81 patients. The abstract does not define organ preservation or give the follow-up time for this figure. The 2025 JAMA Surgery report gives 77.8% (63 of 81) of the CRT-TEM mITT group as having a preserved rectum at longer follow-up. |
| pCRCRT-TEM group, 79 patients with pathology available as printed in the abstract (35 of 79)Pathological complete response in the CRT-TEM group | interimSerra-Aracil 2023 | 44.3% | — | 35 of 79 patients. |
| Endpoint | Analysis | Chemoradiotherapy and transanal endoscopic microsurgery | Total mesorectal excision | Effect |
|---|---|---|---|---|
| Locoregional recurrence of rectal cancer5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)Main outcome of TAU-TEM: locoregional recurrence in the 5-year modified intention-to-treat analysis, given as the number of patients with recurrence among 81 per group. The abstract's objective is recurrence after 2 years of follow-up with a one-sided noninferiority margin of 10%. | primarySerra-Aracil 2025 | 7.4% | 6.2% | 6 of 81 patients with chemoradiotherapy and local excision and 5 of 81 with total mesorectal excision. The abstract and the full text print the difference as -1.23% (it equals the TME percentage minus the CRT-TEM percentage) with an interval of '6.51% to -8.98%', upper bound first. The Results compare the lower bound, -8.98, with the 10% margin and conclude noninferiority; the Results text calls the interval one-sided 97.5%, while the footnote of Table 2 calls it one-sided at the 95% level. Full text only: P = .76 is printed beside the difference; in the per-protocol analysis CRT-TEM had 5 of 66 (7.6%); median follow-up was 63 months (IQR 40 to 86) for the analysed patients. The abstract does not say how the 5-year proportions were estimated. |
| Distant recurrence of rectal cancer5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)Distant recurrence in the 5-year modified intention-to-treat analysis (secondary outcome), given as the number of patients with recurrence among 81 per group. | long term-updateSerra-Aracil 2025 | 12.3% | 17.3% | 10 of 81 patients with chemoradiotherapy and local excision and 14 of 81 with total mesorectal excision. The abstract prints the difference as 4.94% (TME minus CRT-TEM) with an interval of '15.85% to -5.98%', upper bound first, and states no P value. The full text states that the study was not powered for secondary outcomes. |
| OS5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)5-year overall survival (secondary outcome), given as the number of patients alive among 81 per group. | long term-updateSerra-Aracil 2025 | 82.7% | 85.2% | 67 of 81 patients with chemoradiotherapy and local excision and 69 of 81 with total mesorectal excision. The abstract prints the difference as 2.47% with an interval of '0.38%-1.78%', which does not contain the difference and matches the interval of the overall survival hazard ratio in the full text; the full text (Results and Table 2) prints the interval for the difference as '13.77% to -8.83%'. The abstract does not say how the 5-year percentages were estimated. |
| DFS5-year modified intention-to-treat analysis: 81 patients in each group (173 randomised: 86 CRT-TEM, 87 TME)5-year disease-free survival (secondary outcome), given as the number of patients disease-free among 81 per group. | long term-updateSerra-Aracil 2025 | 88.9% | 88.9% | 72 of 81 patients in each group. The abstract prints an interval of '9.68 to -9.68' for the difference between the groups and states no P value. In the full text, Table 2 gives 72 of 81, but one sentence of the Results gives 73 of 81. |
| Postoperative morbidityModified intention-to-treat analysis: 81 patients in each group; the abstract's morbidity denominators are 82 (CRT-TEM) and 81 (TME)Postoperative morbidity (surgical complications graded by the Clavien-Dindo and Comprehensive Complication Index classifications), short-term report | interimSerra-Aracil 2023 | 20.7% | 50.6% | P<0.00117 of 82 patients versus 41 of 81, as printed in the abstract; the denominator of 82 does not match the 81 patients stated for the analysis. The abstract also prints a 95% confidence interval of '42.9% to 16.7%', which is not stored. One patient died in each group. The 2025 JAMA Surgery report repeats the figure as 17 of 82 (20.7%) in its text and as 17/81 (20.7%) in its Table 1; 17 of 81 would be 21.0%, so the published percentage is kept. This is a short-term report; the trial's cancer outcomes (2025) are recorded as separate results. |
| Organ preservation rate81 patients in the CRT-TEM group who received the allocated treatmentPatients who underwent organ preservation among those who received the allocated CRT-TEM treatment (short-term report) | interimSerra-Aracil 2023 | 82.7% | — | 67 of 81 patients. The abstract does not define organ preservation or give the follow-up time for this figure. The 2025 JAMA Surgery report gives 77.8% (63 of 81) of the CRT-TEM mITT group as having a preserved rectum at longer follow-up. |
| pCRCRT-TEM group, 79 patients with pathology available as printed in the abstract (35 of 79)Pathological complete response in the CRT-TEM group | interimSerra-Aracil 2023 | 44.3% | — | 35 of 79 patients. |
Appears in
Sources
Serra-Aracil X, Pericay C, Badia-Closa J, Golda T, Biondo S, Hernández P, et al. 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;34(1):78-90.
Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, et al. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025;160(7):783-793.