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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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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| author | Li Shaotang |
| author_facet | Li Shaotang |
| author_sort | Li Shaotang |
| collection | DOAJ |
| description | [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. |
| format | Article |
| id | doaj-art-2d092d61ea0642a3bfbdd89ebca33906 |
| institution | Kabale University |
| issn | 1674-0491 |
| language | zho |
| publishDate | 2022-04-01 |
| publisher | Editorial Office of Journal of Colorectal & Anal Surgery |
| record_format | Article |
| series | 结直肠肛门外科 |
| spelling | doaj-art-2d092d61ea0642a3bfbdd89ebca339062025-08-20T03:28:48ZzhoEditorial Office of Journal of Colorectal & Anal Surgery结直肠肛门外科1674-04912022-04-0128217717710.19668/j.cnki.issn1674-0491.2022.02.016The 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 trialLi Shaotang0Department of Colorectal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, Zhejiang, China[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.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 |
| spellingShingle | Li Shaotang 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 结直肠肛门外科 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | 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 |
| work_keys_str_mv | AT lishaotang theconventionaltechniqueversusthenotouchisolationtechniqueforprimarytumorresectioninpatientswithcoloncancerjcog1006amulticenteropenlabelrandomizedphaseiiitrial AT lishaotang conventionaltechniqueversusthenotouchisolationtechniqueforprimarytumorresectioninpatientswithcoloncancerjcog1006amulticenteropenlabelrandomizedphaseiiitrial |