TaLaR
Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial
Phase 3N = 1,115NCT02966483
- Population
- Patients with clinical stage I to III mid-low rectal cancer
- Design
- Randomised, open-label, non-inferiority phase 3 trial at 16 centres in China. Between April 2016 and June 2021, 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled and randomised 1:1 before surgery to transanal TME (558) or laparoscopic TME (557); last follow-up June 2024. Primary end point 3-year disease-free survival with a non-inferiority margin of -10 percentage points; secondary outcomes included 3-year overall survival and 3-year local recurrence.
- Primary endpoint
- DFS
- Arms
- Laparoscopic TME (control, n = 557): Laparoscopic total mesorectal excision
- Transanal TME (experimental, n = 558): Transanal total mesorectal excision
- People
- Zeng Z, Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group
Δ 36-month DFS+2.7 pointsΔ 36-month Local recurrence after rectal surgery−0.8 pointsΔ 36-month OS+1.9 points
Show the numbers
| Endpoint | Analysis | Transanal TME | Laparoscopic TME | Effect |
|---|---|---|---|---|
| DFSPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year disease-free survival (primary end point) | primaryZeng 2025 | 82.1% at 3 y | 79.4% at 3 y | 97.5% confidence intervals (not 95%): transanal 78.4 to 85.8, laparoscopic 75.6 to 83.4; difference 2.7 percentage points (97.5% CI -3.0 to 8.1). The full text gives a hazard ratio of 0.86 (97.5% CI 0.63 to 1.18). The lower limit was above the non-inferiority margin of -10 percentage points, and the abstract concludes that transanal TME was non-inferior. |
| Local recurrence after rectal surgeryPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year local recurrence (secondary outcome) | primaryZeng 2025 | 3.6% at 3 y (2.0–5.1%) | 4.4% at 3 y (2.6–6.1%) | — |
| OSPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year overall survival (secondary outcome) | primaryZeng 2025 | 92.6% at 3 y (90.4–94.8%) | 90.7% at 3 y (88.3–93.2%) | — |
| Endpoint | Analysis | Transanal TME | Laparoscopic TME | Effect |
|---|---|---|---|---|
| DFSPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year disease-free survival (primary end point) | primaryZeng 2025 | 82.1% at 3 y | 79.4% at 3 y | 97.5% confidence intervals (not 95%): transanal 78.4 to 85.8, laparoscopic 75.6 to 83.4; difference 2.7 percentage points (97.5% CI -3.0 to 8.1). The full text gives a hazard ratio of 0.86 (97.5% CI 0.63 to 1.18). The lower limit was above the non-inferiority margin of -10 percentage points, and the abstract concludes that transanal TME was non-inferior. |
| Local recurrence after rectal surgeryPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year local recurrence (secondary outcome) | primaryZeng 2025 | 3.6% at 3 y (2.0–5.1%) | 4.4% at 3 y (2.6–6.1%) | — |
| OSPrimary analysis set: 1089 patients (544 transanal TME, 545 laparoscopic TME; 692 men and 397 women), excluding patients later found not to meet the inclusion criteria (primary analysis set and per-protocol population were identical; full text)3-year overall survival (secondary outcome) | primaryZeng 2025 | 92.6% at 3 y (90.4–94.8%) | 90.7% at 3 y (88.3–93.2%) | — |