-
Randomized Controlled Trial Multicenter Study
The Conventional Technique Versus the No-Touch Isolation Technique for Primary Tumor Resection in Patients With Colon Cancer (JCOG1006): A Multicenter, Open-Label, Randomized, Phase III Trial.
- Yasumasa Takii, Junki Mizusawa, Yukihide Kanemitsu, Koji Komori, Manabu Shiozawa, Masayuki Ohue, Satoshi Ikeda, Nobuhiro Takiguchi, Takaya Kobatake, Hideyuki Ike, Toshihiko Sato, Naohiro Tomita, Mituyoshi ... more
- Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
- Ann. Surg. 2022 May 1; 275 (5): 849-855.
ObjectiveThis phase III trial evaluated whether the no touch was superior to the conventional in patients with cT3/T4 colon cancer.BackgroundNo 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.MethodsThis 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, andM0; 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.ResultsBetween 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.ConclusionThe present study failed to confirm the superiority of the no touch.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
Notes