Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer

Sex

All

Minimum age

21 Years

Maximum age

74 Years

Inclusion Criteria:

Preoperative criteria:

1. Histologically confirmed adenocarcinoma
2. Clinical stage II or III
3. Preoperative findings:

   * Main lesion of the tumor is located at the rectum
   * Lower tumor margin is below the peritoneal reflection
   * No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
   * No invasion to other organ (s)
4. Patient age is more than 20 and less than 75
5. PS: 0, 1
6. No past history of chemotherapy, pelvic surgery or radiation
7. Written informed consent

   Operative criteria:
8. Mesorectal excision is performed
9. Operative findings:

   * Main lesion of the tumor is located at the rectum
   * Lower tumor margin is below the peritoneal reflection
10. R0 after resection

Exclusion Criteria:

1. Multiple cancer patients
2. Pregnant patients
3. Psychological disorder
4. Steroid administration
5. Cardiac infarction within six months
6. Severe pulmonary emphysema and pulmonary fibrosis
7. Doctor's decision for exclusion

• DERIVEDTsukamoto S, Fujita S, Ota M, Mizusawa J, Shida D, Kanemitsu Y, Ito M, Shiomi A, Komori K, Ohue M, Akazai Y, Shiozawa M, Yamaguchi T, Bando H, Tsuchida A, Okamura S, Akagi Y, Takiguchi N, Saida Y, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Long-term follow-up of the randomized trial of mesorectal excision with or without lateral lymph node dissection in rectal cancer (JCOG0212). Br J Surg. 2020 Apr;107(5):586-594. doi: 10.1002/bjs.11513. Epub 2020 Mar 12. PMID 32162301
• DERIVEDSaito S, Fujita S, Mizusawa J, Kanemitsu Y, Saito N, Kinugasa Y, Akazai Y, Ota M, Ohue M, Komori K, Shiozawa M, Yamaguchi T, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Male sexual dysfunction after rectal cancer surgery: Results of a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for patients with lower rectal cancer: Japan Clinical Oncology Group Study JCOG0212. Eur J Surg Oncol. 2016 Dec;42(12):1851-1858. doi: 10.1016/j.ejso.2016.07.010. Epub 2016 Jul 30. PMID 27519616
• DERIVEDFujita S, Akasu T, Mizusawa J, Saito N, Kinugasa Y, Kanemitsu Y, Ohue M, Fujii S, Shiozawa M, Yamaguchi T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Postoperative morbidity and mortality after mesorectal excision with and without lateral lymph node dissection for clinical stage II or stage III lower rectal cancer (JCOG0212): results from a multicentre, randomised controlled, non-inferiority trial. Lancet Oncol. 2012 Jun;13(6):616-21. doi: 10.1016/S1470-2045(12)70158-4. Epub 2012 May 15. PMID 22591948