• Annals of surgery · May 2022

    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 Ota, Tadahiko Masaki, Tetsuya Hamaguchi, Dai Shida, Hiroshi Katayama, Yasuhiro Shimada, Haruhiko Fukuda, and Colorectal Cancer Study Group of Japan Clinical Oncology Group (JCOG).
    • 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.

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