RecruitingNot ApplicableNCT03587480

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

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

250 participants

Start Date

Dec 17, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for rectal cancer: one where surgery alone removes the rectum along with nearby lymph nodes on the sides of the pelvis (lateral lymph node dissection), versus a two-step approach where chemotherapy and radiation are given first, followed by standard surgery. **You may be eligible if...** - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy, located below the peritoneal fold (the lower part of the rectum) - Your cancer is at clinical stage III (T1–T3 with lymph node involvement, no distant spread) - Your tumor can be fully removed with surgery - You have not previously received chemotherapy or pelvic radiation for any cancer - Your treatment plan has been confirmed by a multidisciplinary team using MRI and rectal ultrasound **You may NOT be eligible if...** - You have a history of other cancers - Your cancer involves the lymph nodes above the peritoneal reflection (upper rectal involvement) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETME+LLND

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

PROCEDURETME+nCRT

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


Locations(1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT03587480


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