Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)

Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212) - Mesorectal excision with lateral lymph node dissection versus without lateral lymph node dissection for clinical stage II, III lower rectal cancer(JCOG0212)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000034

Enrollment

700

Registered

2005-08-01

Start date

2003-06-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II, III lower rectal cancer

Interventions

Mesorectal excision with lateral lymph node dissection Mesorectal excision without lateral lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preoperative criteria 1) Histologically confirmed adenocarcinoma 2) Clinical stage II or III 3) Preoperative findings (i) Main lesion of the tumor is located at the rectum (ii) Lower tumor margin is below the peritoneal reflection (iii) No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm) (iv) No invasion to other organ (s) 4) No multiple colorectal cancers 5) Patient age is more than 20 and less than 75 6) PS: 0, 1 7) No past history of chemotherapy, pelvic surgery or radiation 8) Written informed consent Operative criteria 9) Mesorectal excision is performed 10) Operative findings (i) Main lesion of the tumor is located at the rectum (ii) Lower tumor margin is below the peritoneal reflection 11) R0 after resection

Exclusion criteria

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	—

Secondary

Measure	Time frame
Overall survival, Local-recurrence-free survival, Incidence of adverse events, Incidence of major adverse events, Operative time, Blood loss, Incidence of sexual and urinary dysfunction	—

Countries

Japan

Contacts

Public ContactShin Fujita, MD

JCOG0212 Coordinating Office Surgery Division, Tochigi Cancer Center

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026