Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• 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 -

Locations
Other Locations
China
The Sixth Affiliate Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yanxin Luo
luoyx25@mail.sysu.edu.cn
020-38250745
Backup
Shaoyong Peng
pengshy9@mail2.sysu.edu.cn
86-13435613566
Time Frame
Start Date: 2018-12-17
Estimated Completion Date: 2030-05-24
Participants
Target number of participants: 250
Treatments
Other: TME+LLND group
Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.
Other: TME+nCRT group
Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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