The conventional technique versus the no-touch isolation tech nique for primary tumor resection in patients with colon cancer (JCOG1006) a multicenter, open-label, randomized, phase Ⅲ trial
[Objective] This phase III trial evaluated whether the no touch was superior to the conventional in patients with cT3/T4 colon cancer. [Background] No touch involves ligating blood vessels that feed the primary tumor to limit cancer cell spreading. However, previous studies did not confirm the effic...
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| Format: | Article |
| Language: | zho |
| Published: |
Editorial Office of Journal of Colorectal & Anal Surgery
2022-04-01
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| Series: | 结直肠肛门外科 |
| Online Access: | https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=441&cateName=2022%E5%B9%B4%20%E7%AC%AC28%E5%8D%B7%20%E7%AC%AC2%E6%9C%9F |
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| Summary: | [Objective] This phase III trial evaluated whether the no touch was superior to the conventional in patients with cT3/T4 colon cancer. [Background] No touch involves ligating blood vessels that feed the primary tumor to limit cancer cell spreading. However, previous studies did not confirm the efficacy of the no touch. [Methods] This open-label, randomized, phase III trial was conducted at 30 Japanese centers. The eligibility criteria were histologically proven colon cancer; clinical classification of T3-4, N0-2, and M0; and patients aged 20 to 80years. Patients were randomized (1:1) to undergo open surgery with conventional or the no touch. Patients with pathological stage III disease received adjuvant capecitabine chemotherapy. The primary endpoint was disease-free survival (DFS) according to the intention-to-treat principle. [Results] Between January 2011 and November 2015, 853 patients were randomized to the conventional group (427 patients) or the no touch group (426 patients). The 3-year DFS were 77.3% [95% confidence interval (CI) 73.1%-81.0%] and 76.2% (95% CI 71.9%-80.0%) in the conventional and no touch groups, respectively. The superiority of no touch was not confirmed: hazard ratio for DFS=1.029 (95% CI 0.800- 1.324; 1-sided P=0.59). Operative morbidity was observed in 31 of 427 conventional patients (7%) and 26 of 426 no touch patients (6%). All grade adverse events were similar between the conventional and no touch groups. No in-hospital mortality occurred in either group. [Conclusion] The present study failed to confirm the superiority of the no touch. |
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| ISSN: | 1674-0491 |