Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • TME+LLND

    Procedure/Surgery

    patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)

  • TME+nCRT

    Procedure/Surgery

    patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: TME+LLND groupOther 1 intervention
Group B: TME+nCRT groupOther 1 intervention

Trial outcomes

Primary outcomes

1

3-year disease-free survival

36 months after surgery

Time frame
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes

1

Operative time

Operation day

Time frame
Operation day
2

Blood loss

in the perioperative period

Time frame
Operation day
3

Incidence of sexual dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Time frame
3 years
4

Incidence of urinary dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Time frame
3 years

Other outcomes

Sponsors and contacts

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