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

UMIN ID: C000000034

Registered date:01/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage II, III lower rectal cancer
• Date of first enrollment: 2003/06/11
• Target sample size: 700
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Relapse-free survival
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00190541