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

  • STATUS
    Recruiting
  • End date
    May 24, 2022
  • participants needed
    250
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
Updated on 23 January 2021

Summary

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

Details
Condition Rectal Neoplasm Malignant
Treatment lateral lymph node dissection(LLDD), neoadjuvant chemo-radiotherapy (nCRT), TME+LLND, TME+nCRT
Clinical Study IdentifierNCT03587480
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage
Tumor is capable of performing radical recession
No past history of chemotherapy, pelvic radiation of other cancers
Written informed consent
Lower tumor margin is confirmed below the peritoneal reflection
Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -

Exclusion Criteria

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
Combine with obstruction,perforation or bleeding which need emergency surgery
Local tumor invade the external sphincter, levator ani muscle or adjacent organs
Participant join other clinical trials in 4 weeks
American Society of Anesthesiologists(ASA) and/or Eastern Cooperative Oncology Group(ECOG) 2
Pregnant or lactating patients
Severity infection before operation
Psychological disorder
Severe dysfunction of organs or other contraindications
Cardiac infarction within six months
Severe pulmonary emphysema and pulmonary fibrosis
Doctor's decision for exclusion
Operative findings
Tumor invade other organs Lower tumor margin is above the peritoneal
reflection
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