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Poster display session

1553 - Short-term clinical outcome from a randomized controlled trial of the conventional technique versus the no-touch isolation technique for primary tumor resection in patients with colon cancer: Japan Clinical Oncology Group study JCOG1006

Date

09 Sep 2017

Session

Poster display session

Presenters

Yasumasa Takii

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

Y. Takii1, K. Komori2, M. Shiozawa3, M. Ohue4, Y. Nishimura5, S. Ikeda6, N. Takiguchi7, T. Kobatake8, H. Ike9, T. Sato10, N. Tomita11, J. Mizusawa12, H. Katayama12, Y. Shimada13, Y. Kanemitsu14

Author affiliations

  • 1 Gastroenterological Surgery, Niigata Cancer Center Hospital, 95185666 - Niigata/JP
  • 2 Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya/JP
  • 3 Gastroenterological Surgery, Kanagawa Cancer Center, Yokohama/JP
  • 4 Gastroenterological Surgery, Osaka International Cancer Institute, Osaka/JP
  • 5 Gastroenterological Surgery, Saitama Cancer Center, Kitaadachi/JP
  • 6 Surgery, Hiroshima Prefectural Hospital, Hiroshima/JP
  • 7 Gastroenterological Surgery, Chiba Cancer Center Hospital, Chiba/JP
  • 8 Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama/JP
  • 9 Surgery, Saiseikai Yokohamashi Nanbu Hospital, Yokohama/JP
  • 10 Surgery, Yamagata Prefectural Central Hospital, Yamagata/JP
  • 11 Division Of Lower Gastrointestinal Surgery, Department Of Surgery, Hyogo College of Medicine, Nishinomiya/JP
  • 12 Multi-institutional Clinical Trial Support Center, National Cancer Center, 104-0045 - Tokyo/JP
  • 13 Clinical Oncology, Kochi Health Sciences Center, 781-8555 - Kochi/JP
  • 14 Colorectal Surgery, National Cancer Center Hospital, Tokyo/JP
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Abstract 1553

Background

The no-touch isolation technique (NTIT) aims to reduce cancer cells flowing from the primary tumor site to liver and other organs by first ligation of blood vessels that feed the primary tumor. A previous randomized controlled trial (RCT) failed to prove its efficacy with statistical significance because of insufficient sample size and many patients being lost to follow-up. We conducted a phase III trial to confirm the superiority of NTIT in patients with cT3/T4 colon cancer.

Methods

Eligibility criteria included histologically proven colon cancer; tumor located in the cecum, ascending, transverse, descending, sigmoid or rectosigmoid colon; T3 or T4; N0-2 and M0; patients age 20-80 years. Patients were randomized preoperatively to either conventional technique (CoT) arm or NTIT arm. Patients with pathological stage III received adjuvant chemotherapy with capecitabine. The primary endpoint was disease-free survival (DFS), and planned sample size was 850 to detect 6% difference in 3-year DFS with one-sided alpha of 5% and power of 80%. Short-term clinical outcomes were compared between the arms. (UMIN-CTR: UMIN000004957).

Results

A total of 853 patients were randomized (CoT: 427, NTIT: 426) between January 2011 to November 2015. Conversion to CoT was needed for 5 (1.2%) patients in NTIT arm. Regarding surgical procedure, there were no differences in operative time (median 172 min: CoT, 178 min: NTIT, p=0.43), and in blood loss (median 69 ml: CoT, 77 ml: NTIT, p = 0.92). Postoperative complications and time to pass first flatus (median 2 days: CoT, 2 days: NTIT, p = 0.64) did not differ between the arms. There was no hospital death in both arms. Regarding radicality of surgery, there were no differences in D3 lymph node dissection rate (96.3%: CoT, 96.2%: NTIT) and pathological R0 resection rate (98.6%: CoT, 96.7%: NTIT).

Conclusions

Operative quality, postoperative course, radicality, morbidity and mortality are similar in two arms. The primary analysis planned for 2019 is pivotal to prove superiority of NTIT to CoT in term of DFS.

Clinical trial identification

UMIN-CTR: UMIN000004957

Legal entity responsible for the study

National Cancer Center

Funding

National Cancer Research and Development Fund (26-A-4, 29-A-3)

Disclosure

All authors have declared no conflicts of interest.

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