About this trial
Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
Tumor is capable of performing radical recession
No past history of chemotherapy, pelvic radiation of other cancers.
Written informed consent
Disqualifiers
Past history of other cancers
Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)
Combine with inflammatory bowl disease(IBD)
Recurrence tumor or invade other organs
Trial design
Parallel
Treatments tested in this trial
TME+LLND
Procedure/Surgerypatients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
TME+nCRT
Procedure/Surgerypatients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)
Treatment groups
Trial outcomes
Primary outcomes
3-year disease-free survival
36 months after surgery
Secondary outcomes
Operative time
Operation day
Blood loss
in the perioperative period
Incidence of sexual dysfunction
From the date of operation until the date of complication,assessed up to 3 years
Incidence of urinary dysfunction
From the date of operation until the date of complication,assessed up to 3 years
Sponsors and contacts
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