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

Conditions

Rectal Neoplasms

Keywords

Rectal Cancer, Lymph Node Dissection, Rectal Surgery, Autonomic Nerves, Stage II, III lower rectal cancer

Brief summary

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

Detailed description

Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Shunsuke Tsukamoto, S. Fujita, Masayuki Ota, Junki Mizusawa, Dai Shida et al. (21 authors)

British journal of surgery2020-03-12105 citations

10.1002/bjs.11513

Mesorectal excision with or without lateral lymph node dissection for clinical stage II, III lower rectal cancer: Long-term follow-up data of Japan Clinical Oncology Group study JCOG0212.

Mitsuyoshi Ota, Shin Fujita, Junki Mizusawa, Yukihide Kanemitsu, Masaaki Ito et al. (20 authors)

Journal of Clinical Oncology2018-05-201 citations

10.1200/jco.2018.36.15_suppl.3607

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.

Saito 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.

2016-07-3093 citations

10.1016/j.ejso.2016.07.010

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.

Fujita 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.

2012-05-15255 citations

10.1016/s1470-2045(12)70158-4

Interventions

PROCEDUREMesorectal excision with lateral lymph node dissection

Mesorectal excision with lateral lymph node dissection

PROCEDUREMesorectal excision without lateral lymph node excision

Mesorectal excision without lateral lymph node excision

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 74 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Relapse-free survival	Until relapsing

Secondary

Measure	Time frame
Local-recurrence-free survival	Until local-recurrence
Incidence of adverse events	5 years
Incidence of major adverse events	5 years
Overall survival	Overall
Blood loss	Operation day
Incidence of sexual and urinary dysfunction	1 year
Operative time	Operation day

Countries

Japan

Outcome results

None listed